Abstract
A stability-indicating high-performance thin-layer chromatography method for determination of benazepril both in bulk and pharmaceutical formulation has been developed and validated as per ICH guidelines. The benazepril was analyzed on pre-coated silica gel GF254 plates using Carbon tetrachloride: Methanol: Triethylamine (7.6: 2.4: 0.1 v/v) as the mobile phase. The concentration of benazepril was determined by densitometry at 240 nm. The method was found to be linear, with r2 = 0.998±0.3347 in the concentration range 200 - 1200 ng per spot. The LOD and LOQ were 19.48 ng and 59.03 ng per spot respectively. Benazepril was subjected to forced degradation like acid and alkali hydrolysis, oxidation, photo and thermal degradation. The drug was found to degrade under acidic, basic, oxidative and thermal conditions. The degraded product was well resolved from the pure drug with significantly different Rf value. In validation, it was found that the method is repeatable, selective and accurate for the estimation of benazepril. The proposed developed stability-indicating HPTLC method can be applied for identification and quantitative determination of benazepril in bulk drug and pharmaceutical formulation.
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