Stability indicating high performance thin-layer chromatography method for simultaneous estimation of ambroxol hydrochloride and loratadine in pharmaceutical dosage form

A simple, sensitive, accurate, precise and rapid stability indicating HPTLC method for simultaneous determination of ambroxol hydrochloride and Loratadine in pharmaceutical dosage form has been developed. The study was performed on TLC aluminum plates precoated with silica gel 60F254 using chloroform: methanol (9:1v/v) as the mobile phase. This system gives compact and dense spots for both ambroxol hydrochloride (Rf value of 0.36±0.003) and loratadine (Rf value of 0.68±0.002). Densitometric analysis of both drugs was carried out in the reflectance absorbance mode at 216 nm. The coefficient of correlation data for the calibration plots showed a good linear relationship with R2 = 0.997 ± 1.1224 in the range of 600-3600 ng for ambroxol hydrochloride and R2 = 0.998 ± 0.0935 in the range of 50-300 ng for loratadine. The method was validated according to ICH guidelines for specificity, precision, robustness and recovery. Stability study shows that the chromatograms of samples from its degradation products were well resolved with significant Rf value.