Abstract
A simple, selective, precise, and sensitive stability-indicating highperformance thin-layer chromatographic (HPTLC) method has been developed and validated for the analysis of zafirlukast both in bulk drug and pharmaceutical dosage form. The separation was performed on a pre-coated silica gel 60 F254 plates using toluene-methanol-acetone (7:2:1 v/v) as mobile phase. Densitometric analysis was performed in reflectance-absorbance mode at 240 nm. The linear regression analysis data for the calibration plot showed good linear relationship with r2 = 0.999 in the range of 50–400 ng spot−1. The mean value of slope and intercept were 15.35 ± 0.341 and 337.81 ± 1.52, respectively. The minimum amount of zafirlukast that could be authentically detected and quantified was 16.43 and 49.80 ng spot−1, respectively. The drug was subjected to acidic, basic, oxidative, photolytic, and thermal conditions. The drug undergoes degradation under acidic, basic, H2O2, photolytic, and oxidative conditions. The degradation products...
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