Abstract
A simple, selective, precise and stability-indicating high-performance thin-layer chromatographic (HPTLC) method for analysis of eprosartan mesylate both as a bulk drug and in formulations was developed and validated. The method employed TLC aluminium plates precoated with silica gel 60F254 as the stationary phase. The solvent system consisted of ethyl acetate: acetonitrile: glacial acetic acid (5: 5: 0.7, v/v/v). This system was found to give compact spots for eprosartan mesylate (Rf value of 0.48 ± 0.02). Densitometric analysis of eprosartan mesylate was carried out in the absorbance mode at 238 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.996 in the concentration range 100-700 ng per spot. The method was validated for specificity, precision, accuracy, limit of detection, limit of quantification and robustness. Statistical analysis proved that the method is specific, precise and accurate for the estimation of said drug. Eprosartan mesylate was subjected to acidic, alkaline, hydrolytic, oxidative and photolytic degradation. As the method could effectively separate the drug from its degradation product, it can be employed as a stability-indicating one.
