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Stability Studies of Thiocolchicoside in Bulk and Capsules Using RP-HPTLC/Densitometry

DOI: 10.1155/2013/142628

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Abstract:

A new stability-indicating reversed-phase high-performance thin-layer chromatographic (RP-HPTLC) method for densitometric analysis of thiocolchicoside was developed and validated. The chromatograms were developed using aluminum plates pre-coated with silica gel 60 RP-18 F254S as a stationary phase and methanol?:?water (70?:?30? ) as a mobile phase. The compact band for thiocolchicoside was observed at value of at an absorption wavelength of 377?nm. The linear regression data for the calibration plots ( ) was found with respect to peak area in the concentration range of 100–600?ng per band. The limit of detection (LOD) and limit of quantification (LOQ) were 9.77?ng and 29.63?ng, respectively. The drug was exposed to acidic and alkaline hydrolysis, oxidation, photo degradation, and dry heat conditions. The peaks of degradation products were well-resolved from the peak of the standard drug with significantly different values. Statistical analysis proved that the established RP-HPTLC method is reproducible, selective, and accurate for the determination of thiocolchicoside in its formulations. The method can effectively separate the drug from its degradation products, and it can be considered as stability-indicating assay. 1. Introduction Thiocolchicoside is chemically 2-demethoxy-2-glucosidoxythicolchicine (Figure 1) [1]. Thiocolchicoside is a semisynthetic sulfur derivative of colchicoside, a naturally occurring glucoside present in the plant Gloriosa superba. Clinically, thiocolchicoside is used for muscle relaxant, anti-inflammatory, and analgesic properties [2]. Few LC-MS-MS methods have been established for the assessment of bioequivalence of thiocolchicoside as a single component [3] and in fixed-dose combination tablet with lornoxicam [4]. Figure 1: Chemical structure of thiocolchicoside. Some analytical methods, such as LC-ESI-MS [5] RP-HPLC [6, 7] and UV-Spectrophotometric [8, 9] have been established for the determination of thiocolchicoside alone in bulk and pharmaceutical formulations. Thiocolchicoside is available in combination with many other drugs; therefore, several methods such as UV-Spectrophotometric [10–13], RP-HPLC [14–18], and HPTLC [19–23] methods have been studied for the determination of thiocolchicoside in combined dosage forms. The International Conference on Harmonization (ICH) guidelines entitled “Stability Testing of New Drug Substances and Products” requires that stress testing can be carried out to elucidate the inherent stability characteristics of the active substance. An ideal stability-indicating method is that which

References

[1]  Ministry of Health & Family Welfare, “Indian Pharmacopoeia,” in Indian Pharmacopoeial Convention, vol. 3, pp. 2213–2215, Ministry of Health & Family Welfare, Ghaziabad, India, 6th edition, 2010.
[2]  M. Carta, L. Murru, P. Botta et al., “The muscle relaxant thiocolchicoside is an antagonist of GABAA receptor function in the central nervous system,” Neuropharmacology, vol. 51, no. 4, pp. 805–815, 2006.
[3]  F. C. W. Sutherland, M. J. Smit, L. Herbst et al., “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,” Journal of Chromatography A, vol. 949, no. 1-2, pp. 71–77, 2002.
[4]  S. Agarwal, A. Das, H. R. Chowhury, A. K. Sarkar, T. K. Chattaraj, and T. K. Pal, “Bioequivalence study of fixed dose combination tablet containing lornoxicam and thiocolchicoside in healthy subjects,” International Journal of Pharmaceutical Sciences Review, vol. 2, no. 10, pp. 2718–2723, 2011.
[5]  D. G. Erika, A. Silvio, and G. Giorgio, “Forced degradation study of thiocolchicoside: characterization of its degradation products,” Journal of Pharmaceutical and Biomedical Analysis, vol. 61, pp. 215–223, 2012.
[6]  A. R. Umarkar, N. S. Rewatkar, D. R. Chaple, L. T. Thote, S. B. Chaudhari, and M. R. Bhurat, “Stability indicating RP-HPLC method for estimation of Thiocolchicoside in capsule dosage forms,” Research Journal of Pharmaceutical, Biological and Chemical Sciences, vol. 2, no. 1, pp. 750–756, 2011.
[7]  R. R. Joshi, K. R. Gupta, K. S. Jinnawar, and S. G. Wadodkar, “Development and validation of stability-indicating RP-HPLC and assay method for determination of thiocolchicoside in capsule,” American Journal of PharmTech Research, vol. 2, no. 1, pp. 590–602, 2012.
[8]  S. K. Acharjya, P. Mallick, P. Panda, and M. M. Annapurna, “Spectrophotometric methods for the determination of thiocolchicoside in bulk and pharmaceutical dosage forms,” Journal of Pharmaceutical Education and Research, vol. 1, no. 1, pp. 51–57, 2010.
[9]  R. R. Joshi and K. R. Gupta, “UV-Spectrophotometric determination of thiocolchicoside in capsule,” Der Pharma Chemica, vol. 2, no. 2, pp. 384–391, 2010.
[10]  A. R. Umarkar, N. S. Rewatkar, M. S. Charde, and R. M. Charde, “Simultaneous estimation of thiocolchicoside and diclofenac potassium by UV spectrophotometer using multicomponent method,” International Journal of ChemTech Research, vol. 3, no. 2, pp. 944–947, 2011.
[11]  S. K. Acharjya, Y. Rajesh, P. Panda, P. Mallick, and M. M. Annapurna, “Spectrophotometric methods for simultaneous estimation of etoricoxib and thiocolchicoside in bulk and combined pharmaceutical dosage form,” Journal of Pharmaceutical Education and Research, vol. 1, no. 1, pp. 75–82, 2010.
[12]  B. G. Chaudhari and J. B. Trivedi, “Simultaneous spectrophotometric estimation of thiocolchicoside and dexketoprofen trometamol in pharmaceutical dosage form,” International Journal of Biomedical and Advance Research, vol. 3, no. 3, pp. 179–183, 2012.
[13]  R. R. Joshi and K. R. Gupta, “Simultaneous UV-Spectrophotometric determination of thiocolchicoside and diclofenac in pharmaceutical formulation,” Der Pharmacia Sinica, vol. 1, no. 2, pp. 44–51, 2010.
[14]  A. R. Umarkar, N. S. Rewatkar, M. S. Charde, and A. V. Kasture, “RP-HPLC method development and validation for estimation of thiocolchicoside and diclofenac potassium in bulk and capsule dosage forms,” Journal of Pharmacy Research, vol. 4, no. 5, pp. 1307–1308, 2011.
[15]  S. Kumar, A. Joshi, R. S. Thakur, A. K. Pathak, and K. Shah, “Simultaneous estimation of etoricoxib and thiocolchicoside by RP-HPLC method in combined dosage forms,” Acta Poloniae Pharmaceutica, vol. 68, no. 6, pp. 839–845, 2011.
[16]  M. Walash, F. Belal, M. Eid, and S. A. El Abass, “Simultaneous HPLC determination of thiocolchicoside and glafenine as well as thiocolchicoside and floctafenine in their combined dosage forms,” Journal of Chromatographic Science, vol. 49, no. 2, pp. 159–164, 2011.
[17]  S. R. Dhaneshwar, K. O. Raut, and V. K. Bhusari, “Validated HPLC method for simultaneous estimation of paracetamol, aceclofenac and thiocolchicoside in bulk drug and formulation,” Research Journal of Pharmaceutical, Biological and Chemical Sciences, vol. 2, no. 2, pp. 435–445, 2011.
[18]  S. M. Bhavsar, D. M. Patel, A. P. Khandhar, and C. N. Patel, “Validated RP-HPLC method for simultaneous estimation of lornoxicam and thiocolchicoside in solid dosage form,” Journal of Chemical and Pharmaceutical Research, vol. 2, no. 2, pp. 563–572, 2010.
[19]  P. Syal, M. Sahoo, R. Raut et al., “Development and validation of an HPTLC method for simultaneous estimation of thiocolchicoside and aceclofenac in combined dosage form,” Journal of Planar Chromatography, vol. 25, no. 2, pp. 133–137, 2012.
[20]  M. Sahoo, P. Syal, A. A. Hable, R. P. Raut, V. P. Choudhari, and B. S. Kuchekar, “Development and validation of HPTLC method for simultaneous estimation of lornoxicam and thiocolchicoside in combined dosage form,” Pharmaceutical Methods, vol. 2, no. 3, pp. 179–183, 2011.
[21]  S. T. Patil, V. K. Bhusari, and S. R. Dhaneshwar, “Validated HPTLC method for simultaneous estimation of thiocolchicoside and aceclofenac in bulk drug and formulation,” International Journal of Pharma and Bio Sciences, vol. 2, no. 2, pp. 482–490, 2011.
[22]  V. S. Rajmane, S. V. Gandhi, U. P. Patil, and M. R. Sengar, “High-performance thin-layer chromatographic determination of etoricoxib and thiocolchicoside in combined tablet dosage form,” Journal of AOAC International, vol. 93, no. 3, pp. 783–786, 2010.
[23]  S. Gandhi, P. Deshpande, and M. Sengar, “High-performance thin-layer chromatographic determination of diclofenac sodium and thiocolchicoside in fixed dose combination,” International Research Journal of Pharmacy, vol. 1, no. 1, pp. 220–224, 2010.
[24]  ICH, “Q1A(R2) stability testing of new drug substances and products,” in International Conference on Harmonization Guidelines, November 2003.
[25]  ICH, Q2(R1) Validation of Analytical Procedures: Text and Methodology, ICH Harmonized Tripartite Guideline, 2005.

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