Stability-indicating HPTLC determination of tizanidine hydrochloride in bulk drug and pharmaceutical formulations.

摘要

A simple, selective, precise and stability-indicating high-performance thin-layer chromatographic method of analysis of tizanidine hydrochloride both as a bulk drug and in formulations was developed and validated. The method employed TLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of toluene-acetone-ammonia (5:5:0.1, v/v/v). This system was found to give compact spots for tizanidine hydrochloride (R(f) value of 0.32+/-0.01). Tizanidine hydrochloride was subjected to acid and alkali hydrolysis, oxidation and photodegradation. Also, the degraded product was well separated from the pure drug. Densitometric analysis of tizanidine hydrochloride was carried out in the absorbance mode at 315 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r(2)=0.9922 in the concentration range 300-1000 ng per spot. The mean value of correlation coefficient, slope and intercept were 0.9922+/-0.002, 0.064+/-0.001 and 38.09+/-1.71, respectively. The method was validated for precision, recovery and robustness. The limits of detection and quantitation were 88 and 265 ng per spot, respectively. The drug does not undergo degradation under acidic and basic conditions. The samples degraded with hydrogen peroxide showed additional peak at R(f) value of 0.12. This indicates that the drug is susceptible to oxidation. Statistical analysis proves that the method is repeatable and selective for the estimation of said drug. As the method could effectively separate the drug from its degradation product, it can be employed as a stability-indicating one.