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
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