Analytical Method for Determination of Thiocolchicoside in marketed Pharmaceutical Preparation: A Review

 

Jadhav Ankush P.*, Datar P.A., Shete R.V.

Department of Pharmaceutical Quality Assurance, Rajgad Dnyanpeeth’s College of Pharmacy,

Bhor-Pune, Maharashtra, Pin-412206.

*Corresponding Author E-mail: jadhavbrand@gmail.com

 

ABSTRACT:

Thiocolchicoside a natural anti-inflammatory glycoside. It is the semi-synthetic derivative of the colchicine. It is a muscle relaxant with anti-inflammatory and analgesic effects. It works through selective binding to the GABA-A receptor. It prevents muscle contractions by activating the GABA inhibitory motor pathway. The article summarizes analytical method including the chromatographic method, LC-MS (Liquid Chromatography-mass spectroscopy), HPLC, GC-MS (Gas chromatography-mass spectroscopy), HPTLC and UV-Visible spectrophotometry techniques for estimation of Thiocolchicoside in biological samples, bulk and pharmaceutical formulation.

 

KEYWORDS: Thiocolchicoside (THC); UV-Spectrophotometry; HPLC; HPTLC; LC-MS; GC-MS

 

 

INTRODUCTION:

Thiocolchicoside a natural anti-inflammatory glycoside. It is the semi-synthetic derivative of the colchicine. It originates from the flower seeds of Superba Gloriosa. It is a muscle relaxant with anti-inflammatory and analgesic effects. It has potent convulsant activity and should not be administered to individuals prone to seizures. It is used in the treatment of orthopedic, traumatic and rheumatologic disorders. It is indicated as an adjuvant drug in the treatment of painful muscle contractures and is indicated in acute spinal pathology, for adults and adolescents 16 years of age and older. Recent studies have examined its effect on muscle tone, stiffness, contractures, and soreness experienced by athletes during sporting competitions.

 

CHEMISTRY:

This compound are phenolic glycosides belongs to the class of organic compounds containing a phenolic structure attached to a glycosyl moiety. Among the sugar units found in natural glycosides are D-glucose, L-Fructose, and L rhamnose. IUPAC name is N-[(10S)-3,4-dimethoxy-14-(methylsulfanyl)-13-oxo-5-{[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}tricyclo[9.5.0.0²,⁷]hexadeca-1(16),2,4,6,11,14-hexaen-10-yl] acetamide. The chemical formula of Thiocolchicoside is C27H33NO10S and molecular weight is 563.6 g/mol.

 

MECHANISM OF ACTION:

Thiocolchicoside acts on muscular contractures by activating the GABA inhibitory pathways because it has a selective and potent affinity for g-aminobutyric acid A (GABA-A) receptors thereby behaving as a potent muscle relaxant. In human cortex the main inhibitory neurotransmitter is Gamma-aminobutyric acid (GABA). GABAergic neurons are involved in the anesthetics, myorelaxation, sedation and in the treatment of anxiolytic. GABA can also modulate heart rate and blood pressure. It acts as a muscle relaxant because it has an affinity for the inhibitory glycine receptors i.e. glycomimetic and GABA mimetic activity. Glycine is an inhibitory neurotransmitter and acts as an allosteric regulator of NMDA (N-methyl-D-aspartate) receptors. It regulate the movement, vision by processing the motor and sensory data. Inhibitory neurotransmitter in spinal cord, allosteric regulator of NMDA receptors.

 

PHARMACOLOGY:

A) Pharmacokinetic properties:

1. Absorption- Thiocolchicoside Cmax occur in 30 min and reach values of 113 ng/mL after a 4 mg dose and 175 ng/mL after an 8 mg dose after IM administration.

2. Distribution- After an IM administration of 8 mg, the apparent volume of distribution of thiocolchicoside is estimated around 42.7 L.

3. Biotransformation-Thiocolchicoside is first metabolized in the aglycon 3-dimethyltiocolchicine after oral administration. It is mainly occurs by intestinal metabolism.

4. Elimination- The apparent t1/2 of thiocolchicoside is 1.5h and the plasma clearance 19.2 L/h after IM administration, total radioactivity is mainly excreted in feces (79%) while urinary excretion represents only 20% in oral administration. No unchanged thiocolchicoside is excreted either in urine or feces.

 

B) Pharmacodynamics:

Thiocolchicoside acts both in contractures with a central cause and in contractures of reflex type, rheumatic and traumatic. Thiocolchicoside acts as a competitive GABA receptor antagonist and inhibits glycine receptors with similar potency as nicotinic acetylcholine receptors. It used in combination with glafenine and meprobamate to tranquilize patients undergoing hysterosalpingography, also it is used in the treatment of painful muscle spasms. It has powerful convulsant activity and should not be used in individuals at risk for seizures.

 

Side effects:

Itching and skin rash, Swelling of face, lips, eyelids, tongue, hands and feet, Fainting and drowsiness, Nausea and Vomiting, Diarrhea, Yellowing of skin and eyes Photosensitivity, Dry mouth, Headache.

 

Dosage Forms and Recommended Dose:

Oral, parenteral and topical formulations of THC are available in India. The maximum recommended oral dose is 8 mg every 12 hours for not more than 7 consecutive days. The maximum intramuscular dose should be 4 mg every 12 hours, for up to 5 days.

 

ANALYTICAL METHODS:

This all are method which are used for determination of Thiocolchicoside in Pharmaceutical formulation and in biological fluids. This are all analytical method are reported during the literature survey. This all reported analytical method with specific condition. The literature reports vast number of analytical methods for the determination of thiocolchicoside in biological matrices, bulk material and the pharmaceutical dosage formulation.

 

1. SPECTROPHOTOMETRY:

In the literature survey were found that 25 UV-Spectrophotometric method have been reported for estimation of Thiocolchicoside single and in combined dosage form.

 

Table no. 1 shows the summery of reported UV-Spectrophotometric methods indicating sample matrix used, lambda Max., Solvent used in it.

 

Table no. 1: Summary of UV-Spectrophotometric methods of Thiocolchicoside.

Sr.

no.

Name of drug

Sample

Method

Wavelength(nm)

Solvent

Ref. no.

Thiocolchicoside

Other

1.   

Thiocolchicoside

Tablets

 

 

Spectrophotometric

410

 

-

Distilled water

1

2.   

Thiocolchicoside + Ketoprofen

Tablets

 

Simultaneous equation

372

251.5

Methanol

2

3.   

Thiocolchicoside + Etodolac

Tablets

A

Simultaneous equation

259.4

223

Methanol

3

B

Q-value analysis

4.   

Thiocolchicoside

Capsule

A

Zero order

259.8

-

Methanol

4

B

Area Under Curve (AUC)

269.8-259.8

5.   

Thiocolchicoside + Desloratadine + Fexofenadine HCL + Etodolac + Moexipril HCL

Capsule

 

Area Under Curve (AUC)

607

-

Distilled water

5

6.   

Thiocolchicoside

Capsule

 

Zero order

257.0

-

Methanol

6

7.   

Thiocolchicoside

Capsule

A

 

Zero derivative spectrum

259.0

-

0.1N NaOH

7

B

First derivative spectrum

 

252.0

 

C

Second derivative spectrum

260.0

 

D

Area Under Curve (AUC)

254.0-264.0

8.

Thiocolchicoside + Diclofenac Potassium

Tablets

A

 

Ratio Derivative

268.78

 

355.62

 

Methanol

8

B

Dual Wavelength

263.22

301.65

9.

Thiocolchicoside + Hydrochloro- thiazide

Tablets

 

Q-absorption ratio

282.60

271

Methanol

9

10.

Thiocolchicoside + Aceclofenac

Tablets

 

Second order derivative

278.2

215.1

Methanol

10

11.

Thiocolchicoside + Dexketoprofen

+ Trometamol

Tablets

 

Dual wavelength data processing program

368

284.60

Methanol

11

12.

Thiocolchicoside + Diclofenac Potassium

Capsule

 

Multicomponent Method

254,259,265,271,286

254,259,265,271,286

Methanol

12

13.

Thiocolchicoside + Paracetamol

+ Aceclofenac

Tablets

 

Multicomponent Method

258

249, 276

Methanol

13

 14.

Thiocolchicoside + Aceclofenac

Tablets

 

Area Under Curve (AUC)

264.5-254.5

279.0-269.0

Methanol

14

15.

Thiocolchicoside + Etodolac

Tablets

 

Multivariate calibration methods

240–440

240-440

Methanol

15

16.

Thiocolchicoside + Diclofenac 

sodium

Capsule

A

Absorbance correction

276.6

 

372.8

 

Methanol

16

B

First order derivative

278.6

243.2

 

C

Dual wavelength

244

269

17.

Thiocolchicoside + Dexketoprofen

Tablets

A

Absorbance correction method

 

 

370

 

255

 

Methanol

17

B

First order derivative spectroscopic

332

242

18.

Thiocolchicoside + Diclofenac

Capsule

A

Simultaneous equation

260

276.5

NaOH

18

B

Absorbance Correction method

373

276.5

19.

Thiocolchicoside

Injection

 

Spectrofluorimetry

289 & 366.

-

-

19

20.

Thiocolchicoside

Capsule

A

Zero order

259.8

 

-

Distilled water

20

B

Area under Curve

269.8- 259.8

21.

Thiocolchicoside + Paracetamol

+ Aceclofenac

Tablets

 

 

Multicomponent mode

 258

 

256,

270

Methanol

21

 

 

22.

Thiocolchicoside + Diclofenac

Capsule

A

Q-value/Analysis

264

259

Methanol

22

B

Simultaneous equation

23.

Thiocolchicoside + Diclofenac

Tablets

A

Absorption correction

264.99

373.84

 

Methanol

23

B

Area Under Curve (AUC)

 

278.51-285.53

252.56-260.59

24.

Thiocolchicoside + Diclofenac

Capsule

 

Simultaneous equation

259

277

Methanol

24

25.

Thiocolchicoside + Diclofenac

Capsule

A

Simultaneous equation

260.0

276.5

 

Methanol

25

B

Absorbance Correction

373.0 nm is Isoabsorptive point

276.5

 

2. CHROMATOGRAPHIC METHODS:

The High performance liquid chromatography (HPLC) for residue determination of single and combined drug and also used in impurity profiling.

 

Table no. 2 shows the summarized reported chromatographic method indicating sample, method, mobile phase and wavelength.

 

ABBREVIATIONS:

THC = Thiocolchicoside, ACN = Acetonitrile, ACE = Aceclofenac, DCFS = Diclofenac Sodium, DCFP = Diclofenac Potassium, DPs = Degradation products, DXKET = Dexketoprofen, ETD = Etodolac, ETR = Etoricoxib, FN = Floctafenine,

 

GF = Glafenine, IM = Intra-muscular, KET = Ketoprofen, M = concentration (mol/L), MP = Mobile Phase, nm = nanometre, OPA = Orthophosphoric Acid, PCM = Paracetamol, TEA = Triethylamine, TFA = Trifluoroacetic Acid.

 

Table no. 2: Summary chromatographic methods of Thiocolchicoside.

Sr.

no.

Drug Name & Combination

Sample

Column

Mobile Phase

Mode of analysis

Wavelength

(nm)

Retention time in min.

Ref. No.

1.   

THC+ ETORICOXIB

Tablets

C-18

(Inertsil)

Acetonitrile: 0.05M ammonium acetate (80:20) pH 6.5

Isocratic

 

240

THC- 9.04,

ETC- 5.01

26

2.   

THC+GF

Tablet MIX-I

C18

(Waters symmetry)

Methanol : 0.035 M phosphate buffer (50:50, v/v) pH 4.5

Isocratic

 

400

THC- 2.56,

GF- 4.5

27

THC+ FN

Tablet MIX-II

Methanol: 0.03M phosphate buffer (70:30, v/v), pH 4

THC- 3.84

FN- 5.88

3.   

THC+

ACE

Tablets

C18 (Inertsil)

Acetonitrile: Water: Methanol (70:20:10, v/v)

Gradient

260

THC- 3.36,

ACE- 4.12

28

4.   

THC+

ETODOLAC

Tablets

C18

(ZODIAC)

Methanol: Acetonitrile: Water 20:60:20 (v/v/v)

Isocratic

 

274

THC- 5.49,

ETD- 7.86

 

29

5.   

THC+

ACE

Tablets

C18 (Thermo)

Acetonitrile: Water: 0.025M pot. dihydrogen orthophosphate buffer (pH adjusted to 3.0 with OPA) (70:10:20, v/v)

Isocratic

260

THC- 2.70,

ACE- 4.76

30

6.   

THC+ACE

Tablets

C18 (Waters symmetry)

Phosphate buffer :Acetonitrile (40:60 v/v)

Isocratic

261

THC- 2.17, ACE- 4.80

31

7.

THC+ACE

Tablets

C18 (Thermo Hypersil

BDS)

Acetonitrile: buffer of pH 6 (42:58,v/v)

Isocratic

261

THC- 4.15,

ACE- 4.88

32

8.

THC+DCF

Capsules

C18 (Inertsil)

Acetonitrile: Methanol: Water (35:15; 50, v/v), pH adjusted to 3.5 with Orthophosphoric acid.

Gradient

286

THC- 3.3,

DCF- 4.0

33

9.

THC+DCF

Tablets

C18 (Waters Symmetry)

Water (pH 9.2adjusted with di- Potassium hydrogen Phosphate) (60: 40, v/v)

Isocratic

223

DCF- 3.229, THC- 4.999

34

10.

THC+

LOR

Tablets

C18 (Waters Symmetry)

Methanol: THF: acetate buffer (60: 10: 30, v/v); pH adjusted to 5.5 with glacial acetic acid

Isocratic

250

LOR- 4.08, THC- 3.36

35

11.

THC+

LOR

Tablets

C18

(Varian)

Methanol: Acetate buffer (PH4.6) :THF(50:35:15, v/v)

Isocratic

375

LOR- 400,

THC- 2.92

36

12.

THC+

LOR

Tablets

C18 (Inertsil ODS 3V)

Ammonium Dihydrogen Phosphate buffer (pH 7.3 with TEA): Methanol (45:55,v/v)

Isocratic

290

LOR- 9.40, THC- 2.96

37

13.

THC+

LOR

Tablets

C8

(X terra)

Sodium Phosphate buffer ( pH 6.8 adjusted with NaOH): ACN (35:65% v/v)

Isocratic

298

LOR- 4.50,

THC- 3.40

38

14.

THC+KET

Tablets

C18

(Thermo scientific)

Acetonitrile: Water: Phosphate buffer (pH 3.0) (60:30:10, v/v)

Isocratic

260

THC- 2.70,

 KET- 4.90

39

15. 

THC+KET

Tablets

C18

Acetonitrile: Water (60:40,v/v)

Isocratic

300

THC- 3.7± 0.1, KET-7.90±0.1

40

16.

THC+DXKET

Tablets

C18

(HS, HiQ sil)

Methanol: Sodium acetate buffer (pH 5 with Glacial acetic acid) (70:30, v/v)

Isocratic

265

THC- 3.013, DXKET- 6.013

41

17.

THC+DXKET

Tablets

RP-18e (Purosphere STAR)

Methanol: Phosphate buffer (pH adjusted to 4.5 with OPA)

(65:35 v/v)

Isocratic

260

THC- 3.02,

DXK- 8.91

42

18.

THC+ETR

Tablets

C-18

(BDS Hypersil)

Trifluoroacetic acid buffer (pH 2.6): Acetonitrile (75:25, v/v)

Isocratic

220

ETR- 6.6,

THC- 3.1

43

19.

THC+ETR

Tablets

C18

(RP-select B Lichrospher)

1 mL TFA in 2 litre milli-Q water) and Acetonitrile (75:25 v/v)

Isocratic

258

THC- 3.37,

ETR- 8.62

44

20.

THC+ETR

Tablets

C18

(InertSil ODS3)

Phosphate buffer (PH 6, adjusted with Orthophosphoric acid) and Methanol (30:70 v/v)

Isocratic

255

THC- 2.50, ETR- 4.60

45

21.

THC+ETD

Tablets

C-18 (Phenomenex)

Methanol and Phosphate buffer pH 6, (85:15 v/v)

Isocratic

259

ETD-4.39±0.10, THC- 3.52±0.10

46

22.

THC+ETD

Tablets

C18

 (HiQ sil HS)

Acetonitrile: 20mM potassium dihydrogen phosphate buffer (65:35 v/v)

Isocratic

257

THC- 2.240, ETD- 7.141

47

23.

THC+ ETORICOXIB

Tablets

C18

(Inertsil)

Acetonitrile: 0.05M ammonium acetate (80:20) pH 6.5

Isocratic

240

THC- 9.04,

ETC- 5.01

48

24.

THC+ETD

Tablets

C18 (Symmetry)

Acetonitrile: Potassium dihydrogen phosphate buffer (pH 3.0) (50:50, v/v

Isocratic

255

ETD- 4.27,

THC- 2.6

49

25.

THC+

PCM

Tablets

C18 (BDS

hypersil)

 

Potassium Dihydrogen phosphate: Methanol (40:60, v/v)

Isocratic

247

PCM- 3.27,

THC- 5.50

50

26.

THC+ ACE+ PCM

Tablets

C18 (HiQ Sil)

Acetonitrile: Water

(30: 70, v/v)

Isocratic

263

PCM- 2.51 THC- 3.55

ACE- 5.20

51

27.

THC+ ACE+ PCM

Tablets

C18 (InertSil ODS)

Buffer of pH 6.5 and Acetonitrile in Gradient elution.

Gradient

300

PCM- 2.70,

THC- 3.95,

ACE- 9.91

52

 

3. HPTLC METHODS FOR DETERMINATION OF THIOCOLCHICOSIDE:

Table no.3 shows the summarized reported HPTLC method indicating sample, mobile phase, linearity, Wavelength and Retention factor.

Table no.3: Summary HPTLC methods of Thiocolchicoside.

Sr.

no.

Drug Name & Combination

Sample

Mobile Phase

Linearity

Wave

length

(nm)

Rf

Ref. No.

1.   

THC+ACE

Tablets

Methanol: Chloroform: Water (9.6: 0.2: 0.2 v/v)

THC 30-180 ng/band ACE 750-4500 ng/band

254

THC- 0.70 ± 0.05, ACE- 0.83 ± 0.05

53

2.   

THC+DXKET

Tablet

Toluene: Ethyl acetate: Methanol (5:3:2 v/v)

THC-50-350 ng/band DXKET-100-700 ng/band

286

THC- 0.10, DXKET- 0.40

54

3.   

THC+DCF

Capsule

Toluene: Acetone: Methanol: Formic acid (5:2:2:0.01 v/v/v/v)

THC 160-800 ng/band DCF 1000-5000 ng/band

280

THC- 0.29±0.02, DCF- 0.71±0.02

55

4.   

THC+ETR

Tablet

Ethyl acetate: Methanol (8 :2 v/v)

THC 100–500 ng/band ETR 50–250 ng/band

290

THC- 0.17,

ETR- 0.70

56

5.   

THC+DCF

Capsule

Toluene: Ethyl acetate: Methanol (5:3:2 v/v)

50-300 ng/band for both

285

THC- 0.17,

DCF- 0.53

57

6.   

THC+DXKET

Tablet

Toluene: Methanol: Ethyl Acetate (6: 2.5: 0.5, v/v)

THC-100-800 ng/band DXKET-600-4800 ng/band

280

THC- 0.33± 0.011, DXKET-0.61± 0.007

58

7.   

THC+LOR

Tablet

Methanol: Chloroform: Water (9.6:0.2:0.2 v/v)

THC 30-180 ng/band LOR 60-360 9ng/ban

377

THC- 0.58±0.05, LOR- 0.85±0.05

59

8.   

THC+ACE

Tablet

Methanol: Chloroform: Water 9.6:0.2:0.2 v/v)

30–180 ng/band THC 750–4500 ng/band ACE

254

THC- 0.70 ± 0.05, ACE- 0.83 ± 0.05

60

9.   

THC+ACE

Tablet

Toluene: Ethyl acetate: Methanol: Glacial acetic acid (4: 6: 2: 0.5 v/v).

THC 6–21 ng/band ACE 10-35 ng/band

255

THC- 0.16,

ACE- 0.79

61

 

4. STABILITY-INDICATING HPLC AND HPTLC METHODS FOR DETERMINATION OF THIOCOLCHICOSIDE:

Table no.4 shows the summarized reported Stability-indicating High Performance Liquid Chromatography & High Performance Thin Layer Chromatography method indicating sample, mobile phase, wavelength and Retention time.

 

Table no.4: Summary Stability-indicating HPLC and HPTLC methods of Thiocolchicoside.

Sr.

no.

Drug Name & Combination

Sample

Mobile Phase

Wave

length

(nm)

Retention time in min.

Ref. No.

 

1

THC+ ACE

Tablets

methanol and 0.1% ortho phosphoric acid of 75:25 (v/v)

275

THC- 1.93,

ACE- 3.76

62

2

THC

Capsule

Acetonitrile: Water (70:30)

286

3.35 min.

6

3

THC+

DCF

Tablet

Solvent A (5 mM sodium dihydrogen phosphate, pH 2.5) and Solvent B (Methanol)

258

THC- 5.8 min., DCF- 11.0 min

64

4

THC

Capsule

Acetonitrile: Phosphate Buffer pH 3.5, (70:30 % v/v

260

2.24 min.

65

5

THC+

ACE

Tablet

(A) 10mM Ammonium acetate pH 5.00 buffer and (B) Acetonitrile: Water (70:30 v/v)

265

THC- 13.29 min, ACF- 2.20 min

66

6

THC+

PCM+ DCF

Capsule

Acetonitrile: Phosphate buffer adjusted pH 3 with OPA

228

PCM - 5.3,

THC- 9.61,

DCF- 21.47

67

7

THC+ACE

Tablet

Potassium phosphate monohydrate buffer (pH-5.0): Acetonitrile: Methanol in (40:20:40 % v/v)

263

THC- 2.8 min.,

ACE- 4.2 min.

68

8

THC+ACE

Tablet

Methanol: Acetonitrile: THF: Acetate buffer (56:4:10:30 v/v) pH adjusted to 6.5 with Acetic acid

312

THC- 4.7 min.,

ACE- 6.3min.

69

9

THC+ KET

Tablet

Methanol: Toluene: Benzene (2.5:3.5:4 v/v)

260

THC- 0.35,

 KET- 0.65 min.

70

 

 

10

THC+DCF

Tablet

Methanol: Acetonitrile : Phosphate buffer (40:20:40 v/v at pH 5.0)

263

THC- 2.8 min., ACE- 4.2 min

71

11

THC+ACE

Tablet

5% ammonium acetate buffer and methanol (40:60 v/v) pH 5 with OPA

276

THC- 0.697 min., ACE- 1.125 min.

72

11

THC

Capsules

methanol: water(70:30v/v)

377

THC- 0.60 ± 0.02

73

 

5. LC-MS (Liquid chromatography-mass spectroscopy) Method:

A highly sensitive Liquid Chromatography–tandem Mass Spectrometry (LC-MS-MS) method has been illustrated for the determination of 3-desmethylthiocolchicine in human plasma to evaluate the bioequivalence of thiocolchicoside after oral administration. The study divulge that thiocolchicoside is rapidly converted to 3-desmethylthiocolchicine (possibly partially in the acidic stomach juices) during absorption and during the first-pass effect through the liver. [74]

A bioanalytical method for the simultaneous estimation of active metabolite of thiocolchicoside (3-demythylthiocolchicine) and diclofenac in human plasma by means of LC-MS/MS is also reported. The method employed Reversed-Phase phenomenex Gemini C18 column with a mobile phase containing Methanol: Water (containing 0.2% formic acid)

 

(9:1, v/v). The calibration curves were linear over the range of 1 to 50 ng/mL for 3-demythylthiocolchicine and 25 to 2500 ng/mL for DCF with the lower limit of quantification validated at 0.5 ng/mL for 3-demythylthiocolchicine and 5 ng/mL for DCF. [75]

 

6. GC-MS (Gas chromatography - mass spectroscopy) Method:

A capillary gas chromatography-mass spectrometry (GC-MS) method is presented for THC following enzymatic hydrolysis of thiocolchicoside to its aglycon (3- dimethyl thiocolchicine). The study reports oral bioavailability of the capsule formulation was 1.06 +/- 0.39 relative to the tablet formulation [76].

 

CONCLUSION:

This reviews articles presented the analytical methods for the estimation of thiocolchicoside & its combination in pharmaceutical dosage form and biological sample like Blood, serum or plasma the literature survey of analytical data exhibit that HPLC methods are primarily for the analysis of Thiocolchicoside in single and in combination with other drugs in various formulation type of dosage form the other analytical methods like RP-HPLC, HPTLC, LCMS, GC-MS, UV-Spectrometry, Spectrofluorimetry and stability indicating methods by HPLC used for the estimation of Thiocolchicoside in single and its combined dosage form, biological sample like blood, serum or plasma and milk. The presented information is useful for future prospective study for researcher in formulation development, Bio analytical research and Quality control of Thiocolchicoside.

 

REFERENCES:

1.      Chinna Raja, Nirmala Jyothi P, Pallavi P, Rafath Sulthana Md, Kiran Kumar G. New spectrophotometric methods for the determination of thiocolchicoside in bulk and pharmaceutical formulations. WJPPS. 2015; 4(5): 1158-1167.

2.      Ankita Bhavsar, Toral Joshi, Kartik Vikani, Arvind Senta. Development and validation of UV-Visible spectrophotometric method for simultaneous estimation of ketoprofen and thiocolchicoside in solid oral dosage form. Int. Res. J. Pharm. 2016; 7(5): 53-58.

3.      Ramchandra Pandey, Pravin O, Patil Sanjay B, Bari Dinesh M, Dhumal. Simultaneous estimation of etodolac and thiocolchicoside in bulk and in tablet formulation by UV-Spectrophotometry. Chem Ind Chem Eng Q. 2014; 20(1): 9-17.

4.      Joshi R.R, Gupta K.R. UV-spectrophotometric determination of thiocolchicoside in capsule. Der Pharm Chem. 2010; 2(2): 384-391.

5.      Soad S Abd El- Hay, Magda Y, El-Mammli, Abdalla A Shalaby. Spectrophotometric Determination of Desloratadine, Fexofenadine HCL, Etodolac, Moexipril HCL and Thiocolchicoside in Pure and Pharmaceutical Formulations, Biotech. Res. Asia. 2011; 8(1): 49-58.

6.      Bhandari A, Nawal M, Jathalia R, Bhandari M, Solanki R, Nagori B.P.S. UV-Spectrophotometric determination of thiocolchicoside from capsule dosage form. J Pharm Res. 2011; 4(12): 4685-4687.

7.      Sasmita Kumari, Priyambada Mallick, Pnakini Panda, M. Mathrusri Annapurna. Spectrophotometric methods for the determination of thiocolchicoside in bulk and pharmaceutical dosage forms. J Pharm Edu Res. 2010; 1(1):51-57.

8.      Choudhari V. Chabukswar A.R, Savakhande S.N, Tryambake M.U, Suryawanshi V, Smsayal P.K. Simultaneous spectrophotometric estimation of thiocolchicoside and diclofenac potassium B.P. in combined dosage form by ratio derivative and dual wavelength method. IJCR. 2010; 2(12): 1-10.

9.      Ghanchi A.A, Maheshwari D.G. Simultaneous estimation of Thiocolchicoside and Hydrochlorothiazide by Q-absorption ratio method. Int J Res Pharm Sci 2015; 5(1): 23-27.

10.   Rajan V.P, Chabukswar A.R, Savakhande S.N, Tryambake M.U, Suryawanshi V.M, Sayal P.K. Simultaneous spectrophotometric estimation of Aceclofenac and Thiocolchicoside by second order derivative method in combined dosage form. J. Chem. Pharm. Res. 2015; 7(7): 1007-1012.

11.   Chaudhari Bharat, Trivedi Jalpesh B. Simultaneous spectrophotometric estimation of thiocolchicoside and dexketoprofen trometamol in pharmaceutical dosage form. IJBAR. 2012; 03(03): 179-183.

12.   Arvind. R, Niki S Rewatkar, Manoj S, Charde, Ritu M Charde. Simultaneous Estimation of Thiocolchicoside and Diclofenac Potassium by UV Spectrophotometer Using Multicomponent Method. IJCRGG. 2011; 3(2): 944-947.

13.   Revankumar D. Nikhade, Ashutosh D. Thakur1, Sunil B. Choudhari, Dr. Anil V. Chandewar. Simultaneous Estimation of Paracetamol, Thiocolchicoside and Aceclofenac by UV Spectrophotometer Using Multicomponent Mode Method. JPR. 2011; 4(7): 2297-2299.

14.   Sohan S. Chitlange, Pradeep S. Shinde, Ganesh R. Pawbake, Sagar B. Wankhede. Simultaneous estimation of Thiocolchicoside and Aceclofenac in pharmaceutical dosage form by spectrophotometric and LC method. Der Pharmacia Lettre. 2010; 2(2): 86-93.

15.   Mevlut Albayrak, Fatma Demirkaya-Miloglu, Onur Senol and Elmas Polatdemir. Design, optimization, and validation of chemo metrics-assisted spectrophotometric methods for simultaneous determination of etodolac and thiocolchicoside in pharmaceuticals, Journal of Analytical Science and Technology. 2019; 10(16): 01-08.

16.   M.R Sengar, S.V Gandhi, U.P Patil, VS Rajmane. Simultaneous determination of diclofenac sodium and thiocolchicoside in fixed dose combination by spectrophotometry. Asian J Pharm Clin Res. 2010; 3(2): 89-91.

17.   M. T. Harde, S. B. Jadhav, D. L. Dharam, P. D. Chaudhari. Development and Validation of UV-Visible Spectrophotometric Methods for Simultaneous Estimation of Thiocolchicoside and Dexketoprofen in Bulk and Tablet Dosage Form. Int J Pharma Sci Drug Res. 2012; 4(2): 160-163.

18.   Rachana R Joshi and Krishna R Gupta. Simultaneous UV-Spectrophotometric determination of Thiocolchicoside and Diclofenac in Pharmaceutical formulation. Der Pharmacia Sinica. 2010; 1(2): 44-51.

19.   Nikhade R.D, Thakur A.D, Choudhari S.B, Chandewar A.V. Simultaneous estimation of paracetamol, thiocolchicoside and aceclofenac by UV-Spectrophotometer using multicomponent mode method. J Pharm Res. 2011; 4(7): 2297-2299.

20.   Rachana R Joshi and Krishna R Gupta. UV-Spectrophotometric Determination of Thiocolchicoside in capsule. Der Pharma Chemica. 2010; 2(2): 384-391.

21.   Wankhede S.B, Zambare S.S, Chitlange S.S. Estimation of thiocolchicoside and ketoprofen in pharmaceutical dosage form by spectrophotometric methods. J Pharm Res. 2010; 3(4): 707-710.

22.   Suganathi A. Ravi T.K. Development of validated spectrofluorometric method for the estimation of thiocolchicoside. Int J Chem Tech Res. 2012; 4(4): 1674-1680.

23.   Umarkar A.R, Bagad Y.M, Rewatkar N.S, Thote L.T. Simultaneous spectrophotometric estimation of thiocolchicoside and diclofenac potassium in combined capsule dosage form. Asian J Res Chem. 2011; 4(3): 370-372.

24.   Choudhari V.P, Chabukswar A.R, Mangesh U.T, Sachin N.S. Spectrophotometric simultaneous determination of diclofenac potassium B.P. and thiocolchicoside in combined tablet dosage form by absorption corrected method and area under curve method. Int J Pharm Sci Rev Res. 2011; 7(2): 182-185.

25.   Sengar M.R, Gandhi S.V, Patil U.P, Rajmane V.S. Simultaneous determination of diclofenac sodium and thiocolchicoside in fixed dose combination by spectrophotometry. Asian J Pharm Clin Res. 2010; 3(2): 89-91.

26.   Dr. Pillai and Deshmukh Nitin. RP-HPLC method for estimation of Etoricoxib and thiocolchicoside from tablet dosage form. WJPPS. 2011; 5(3): 1499-1505.

27.   Walash M, Belal F, Eid M, Abo ES. Simultaneous HPLC determination of thiocolchicoside and glafenine as well as thiocolchicoside and Floctafenine in their combined dosage forms. J Chromatogr Sci. 2011; 49: 159-164.

28.   Chaudhari S.B, Bais Y.G, Umarkar A.R. Development of RP-HPLC method for simultaneous estimation of thiocolchicoside and aceclofenac in their pharmaceutical preparation. J Pharm Res. 2011; 4(10): 3638-3640.

29.   N. Sai, M. Prasadarao and G. Anil. Method development and validation of RP-HPLC for simultaneous estimation of etodolac & thiocolchicoside. WJPR. 2016; 7(7): 1321-1330.

30.   Chitlange S.S, Shinde P.S, Pawbake G.R, Wankhede S.B. Simultaneous estimation of thiocolchicoside and aceclofenac in pharmaceutical dosage form by spectrophotometric and LC method. Der Pharmacia Lett. 2010; 2(2): 86-93.

31.   Reddy V.S, Dutt K.R. Development and validation of RP-HPLC method for simultaneous estimation of Aceclofenac and Thiocolchicoside in tablet dosage form. Int J Pharm Anal Res. 2014; 3 (1): 30-37.

32.   Rele R.V, Sawant S.A. Simultaneous determination of aceclofenac and thiocolchicoside in formulation by reversed phase high performance liquid chromatography. Am J Pharm Tech Res. 2012; 2(4): 45-49.

33.   Umarkar A.R. Rewatkar N.S, Charde M.S, Charde R.M, Kasture A.V. RP-HPLC method development and validation for estimation of thiocolchicoside and diclofenac potassium in bulk and capsule dosage forms. J Pharm Res. 2011; 4(5): 1307-1308.

34.   Sabitha M, Mahaboobsubhani M, Reddy CBS. Analytical method development and validation for the simultaneous estimation of diclofenac sodium and thiocolchicoside in tablet dosage form by using RP-HPLC. Int Res J Pharm Appl Sci. 2014; 4(2): 1-13.

35.   Sahoo M, Syal P, Ingale. Development and validation of a RP-HPLC-PDA method for simultaneous determination of lornoxicam and thiocolchicoside in pharmaceutical dosage form and its application for dissolution study. Int J Res Pharm Sci. 2011; 2(1): 1-17.

36.   Modi M.V, Patel M.M, Patel C.N. Development and validation of analytical method for the determination of lornoxicam and Thiocolchicoside in pharmaceutical dosage form by reversed-phase HPLC. Int J Chem Tech Res. 2011; 3(3): 1259-1264.

37.   Bhavsar S.M, Patel D.M, Amit APK, Patel C.N. Validated RP-HPLC method for simultaneous estimation of Lornoxicam and Thiocolchicoside in solid dosage form. J Chem Pharm Res. 2010; 2(2): 563-572.

38.   Harikiran O.V, Rao M.P, Rao D.N, Gayathri D.K, Sivasankar R.B. Development and validation of a RP-HPLC method for simultaneous determination of lornoxicam and thiocolchicoside in Pharmaceutical dosage form. Int J Pharm Integr Life Sci. 2013; 1(11): 15-20.

39.   Wankhede S.B, Zambare S.S, Dixit N.R, Chitlange S.S. RP-HPLC method for simultaneous estimation of thiocolchicoside and ketoprofen in combined dosage form. Der Pharma Lett. 2010; 2(3): 315-320.

40.   Abirami G, Vetrichelvan T. A new RP-HPLC method for simultaneous estimation of thiocolchicoside and ketoprofen in tablet dosage form. World J Pharm Pharm Sci. 2015; 3(2): 2564-2575.

41.   Bhavnani V.S, Gandhi S.V, Deshpande P.B, Dhiware A.D, Potawale S.E. A simple and sensitive RP-HPLC method for simultaneous estimation of dexketoprofen and thiocolchicoside in combined tablet dosage form. Der Pharm Sin. 2012; 3(4): 433-436.

42.   Harde M.T, Dharam D.L, Jadhav S.B, Balap A.R. Development and validation of RP-HPLC method for simultaneous estimation of thiocolchicoside and dexketoprofen in bulk and tablet dosage form. Int J PharmTech Res. 2012; 4(4): 1797-1802.

43.   Kumar S, Joshi A, Thakur R.S, Pathak A.K, Shah K. Simultaneous estimation of Etoricoxib and thiocolchicoside by RP-HPLC method in combined dosage forms. Acta Pol Pharm Drug Res. 2011; 68(6): 839-8345.

44.   Goyal N, Bhandari A, Jain S, Patel R. Method development and validation of Etoricoxib and thiocolchicoside in combined pharmaceutical solid dosage form by RP-HPLC method. Int J Pharm Stud Res. 2011; 2: 106-109.

45.   Suresh K.S, Natraj D, Khan A, Kumar KB, Rao V.J. Development and validation of RP-PLC method for simultaneous estimation of Etoricoxib and thiocolchicoside in pharmaceutical dosage forms. Int J Res Pharm Chem. 2011; 1(3): 649-653.

46.   Rathod K, Patel J. Simultaneous estimation of etodolac and thiocolchicoside in their combined marketed formulation by RP-HPLC. Int PharmTech Res. 2012; 4(4): 1513-1519.

47.   Dhiware A.D, Gandhi S.V, Deshpande P.B, Bhavnani V.S. A Simple and sensitive RP-HPLC method for simultaneous estimation of etodolac and thiocolchicoside in combined tablet dosage form. Int J Pharm Pharm Sci. 2012; 4(4): 214-216.

48.   Dr. Pillai Sujit, Deshmukh Nitin. RP-HPLC method for estimation of Etoricoxib and Thiocolchicoside from tablet dosage form. WJPPS. 2016; 5(3): 1499-1505.

49.   Alagar R.M, Priyadarshini C.H, David B, Rao KNV, Selvakumar D. Validated RP-HPLC method for simultaneous estimation of etodolac & thiocolchicoside in pharmaceutical tablet dosage form. J Pharm Res. 2012; 5(8): 4577-4579.

50.   Chiragkumar M, Patel B.M, Kunal D.B, Ronak A.P, Smit A.S, Joshi P.R. Development and validation of analytical method for simultaneous estimation of paracetamol and thiocolchicoside by RP-HPLC in bulk and pharmaceutical dosage form. Pharm Sci Mont. 2013; 4(3): 296-306.

51.   Dhaneshwar S.R, Raut K.O, Bhusari V.K. Validated HPLC method for simultaneous estimation of paracetamol, aceclofenac and thiocolchicoside in bulk drug and formulation. Res J Pharm Bio Chem Sci. 2011; 2(2): 435-445.

52.   Rele R.V, Mali R.N. Advance simultaneous determination of paracetamol, thiocolchicoside and aceclofenac in tablets by reverse phase high performance liquid chromatography. Der Pharm Sin. 2014; 5(1): 34-39.

53.   Siyal P, Swarnkar G, Sahoo M. The development and validation of HPTLC method for the simultaneous estimation of thiocolchicoside and aceclofenac in pharmaceutical dosage form. Int J Pharm Erud. 2011; 1(3): 1-9.

54.   Harde M, Dharam D, Jadhav S, Chaudhari P, Balap A. Development and validation of HPTLC method for the simultaneous estimation of thiocolchicoside and dexketoprofen in bulk and tablet dosage form. J Pharm Res. 2012; 5(8): 4143-4146.

55.   Shrivastav J, Shah K, Mahadik M, Dhaneshwar S.R. Application of HPTLC in the simultaneous estimation of thiocolchicoside and diclofenac in bulk drug and pharmaceutical dosage form. Bull Pharm Res. 2011; 1(3): 34-37.

56.   Rajmane V.S, Gandhi S.V, Patil UP, Mahimar S. High-performance thin-layer chromatographic determination of Etoricoxib and thiocolchicoside in combined tablet dosage form. J AOAC Int. 2010; 93(3): 783-786.

57.   Gandhi S, Deshpande P, Sengar M. High performance thin layer chromatographic determination of diclofenac sodium and Thiocolchicoside in fixed dose combination. Int Res J Pharm. 2010; 1(1): 220-224.

58.   Bhavnani V.S, Gandhi S.V, Deshpande P.B, Dhiware A.D. High Performance Thin Layer Chromatographic determination of dexketoprofen and thiocolchicoside in combined tablet dosage form. J Chem Pharm Res. 2012; 4(6): 3324-3328

59.   Sahoo M. Sayal P, Hable A.A, Raut R.P, Chaudhari V.P, Kuchekar B.S. Development and Validation of HPTLC Method for the Simultaneous Estimation of Lornoxicam and Thiocolchicoside in Bulk and Tablet Dosage Form. Pharm Method. 2011; 2(3): 178-183.

60.   Syal P, Sahoo M, Raut R.P. Development and validation of an HPTLC method for simultaneous estimation of thiocolchicoside and aceclofenac in combined dosage form. J Planar Chromatogr. 2012; 25(2): 133-137.

61.   Patil S.T, Bhusari V.K, Dhaneshwar S.R. Validated HPTLC method for simultaneous estimation of thiocolchicoside and aceclofenac in bulk drug and formulation. Int J Pharm Bio Sci. 2011; 2(2): 482-490.

62.   Santoshi G. and Annapurna. Evaluation of A New Stability Indicating Method for the Determination of Aceclofenac and Thiocolchicoside in Pharmaceutical Dosage form By RP-HPLC, Orient. J. Chem. 2017; 33(3): 1337-1346.

63.   Umarkar R. Rewatkar N.S, Chaple D.R, Thote L.T, Chaudhari S.B, Bhurat M.R. Stability Indicating RP-HPLC method for estimation of thiocolchicoside in capsule dosage forms. Res J Pharm Bio Chem Sci. 2011; 2(10): 750-756.

64.   Jadhav S.D, Butle S.R, Patil S.D, Jagtap P.K. Validated stability indicating RP-HPLC method for simultaneous determination and in vitro dissolution studies of thiocolchicoside and diclofenac potassium from tablet dosage form. Arab J Chem. 2011; 01-11. (doi:10.1016/j.arabjc.2011.01.018)

65.   Joshi R.R, Gupta K.R, Jinnawar K.S, Wadodkar S.G. Development and validation of stability indicating RP-HPLC method for determination of thiocolchicoside in capsule. Am J Pharm Tech Res. 2012; 2(1): 590-602.

66.   Samanthula G, Shrigod V.V, Patel P.N. Validated stability indicating assay method for simultaneous determination of aceclofenac and thiocolchicoside using RP-HPLC. Drug Res. 2014; 64(8): 429-435.

67.   Deshpande S, Patel A.R. Stability indicating simultaneous estimation of Thiocolchicoside, Paracetamol and diclofenac sodium in bulk drug and formulation by RP-HPLC. World J Pharm Sci. 2014; 2(7): 671-678.

68.   Ganta S, Suryadevara V, Ganji R, Srilakshmi V. Method development and validation of stability indicating RP-HPLC method for simultaneous estimation of thiocolchicoside and aceclofenac in bulk and its pharmaceutical formulations. Int J Bioassays. 2014; 3(04): 2059-2065.

69.   Choudhari V.P, Chabukswar A.R, Savakhande S.N, Tryambake M.U, Suryawanshi V, Smsayal P.K. Development and validation of Stability-indicating RP-HPLC-PDA method for simultaneous analysis of thiocolchicoside and aceclofenac in pharmaceutical dosage form. J Pharm Res. 2011; 4(6): 1820-1823.

70.   Wankhede S.B, Chitlange S.S, Bhole R.P, Zambare S.S. A simple and sensitive HPTLC method for simultaneous analysis of Thiocolchicoside and Ketoprofen in combined dose tablet formulation. Anal Chem Lett. 2012; 2(5): 301-308.

71.   Satynarayana M. Satyadev T.N, Ganji R, Anuradha V. Method development and validation of stability indicating RP-HPLC method for simultaneous estimation of thiocolchicoside and diclofenac in bulk and its pharmaceutical formulations. Indo Am J Pharm Res. 2014; 4(3): 1-14.

72.   Balan P, Kannappan N. Development and validation of stability indicating RP-UPLC method for simultaneous estimation of thiocolchicoside and aceclofenac in combined dosage form. Int Curr Pharm J. 2014; 3(7): 296-300.

73.   Dnyansing K. Stability Studies of Thiocolchicoside in Bulk and Capsules Using RP-HPTLC/Densitometry. JAMC. 2013. Vol. 2013; ArticleID-142628: 1-7.

74.   Sutherland .C, Smit M, Herbst J. Highly specific and sensitive liquid chromatography–tandem mass spectrometry method for the determination of 3-desmethylthiocolchicine in human plasma as analyte for the assessment of bioequivalence after oral administration of thiocolchicoside. J Chromatogr A. 2002; 949(1-2): 71-77.

75.   Tapan K.P. Bioanalytical method development and validation for the simultaneous estimation of active metabolite thiocolchicoside and diclofenac in human plasma by LCMS/MS with a special emphasis to bioequivalence study. JBA. 2013; 5(3): 1-12.

76.   Perucca E, Poitou P, Pifferi G. Comparative pharmacokinetics and bioavailability of two oral formulations of thiocolchicoside, a gabamimetic muscle relaxant drug, in normal volunteers. Eur J Drg Met Pharmacok. 1995; 20(4): 301-305.

77.   Sandouk P. Bouvier M, Chretien P, Tillement JP, Scherrmann J.M. Single-dose bioavailability of oral and intramuscular thiocolchicoside in healthy volunteers. Biopharm Drug Dispos. 1994; 15(1): 87-92.

78.   Trellua M Filali-Ansary A, Francon D, Adam R, Luel P.L. New metabolic and pharmacokinetic characteristics of THC and its active metabolite in healthy humans. Fund Clin Pharm. 2004; 18: 493-501.

79.   Jana S, Shekhawat G. Critical review on medicinally potent plant species: Gloriosa superb. Fitoterapia. 2011; 82: 293-301.

80.   Janbroers M. Review of the toxicology, pharmacodynamics and pharmacokinetics of THC, a GABA-agonist muscle relaxant with anti-inflammatory and analgesic actions. Acta Therap. 1987; 13: 221-227.

 

 

Received on 15.12.2019            Accepted on 28.12.2019     

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Int. J. Tech. 2019; 9(2):45-53.

DOI: 10.5958/2231-3915.2019.00011.7