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.
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Received on 15.12.2019 Accepted on 28.12.2019 © EnggResearch.net All Right Reserved Int. J. Tech. 2019; 9(2):45-53. DOI: 10.5958/2231-3915.2019.00011.7 |
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