A sensitive and reproducible method is described for the quantitative determination of telmisartan in the presence of its degradation products. Separation was carried out on Merck HPTLC aluminium sheets of silica gel 60 F254 using ethyl acetate: benzene: methanol (9.0: 6.5: 3.5, v/v/v) as mobile phase. This system was found to give compact spots for telmisartan after double development (Rf value of 0.51 ? 0.02). The second order polynomial regression analysis data was used for the regression line in the range of 500-6000 ng/spot. The method has been successively applied to pharmaceutical formulation. No chromatographic interference from the tablet excipients was found. Method was validated in terms of precision, robustness, recovery and limits of detection and quantitation. Drug was subjected to acid and alkali hydrolysis, oxidation, dry heat, wet heat treatment and photo degradation. Significant degradation was observed in all stress conditions. An attempt was made to separate the acid degradation product using preparative TLC and was further identified by LC-MS. The developed method could effectively separate the drug from its degradation products, so it can be employed as stability indicating method for routine quality control of telmisartan.
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