Method Development and Validation by Reverse Phase high Performance Liquid Chromatography for Simultaneous Estimation of Omeprazole and Drotaverine Hydrochloride in Bulk and Pharmaceutical Dosage form

摘要

A validation method of omeprazole and drotaverine hydrochloride from combined dosage form i.e. tablets was described by reverse phase high performance liquid chromatography method. The separation of both drugs was carried on column like BDS Hypersil C18 (150 x 4.6 mm i.d.) with as 5 i particle size. The ratio of mobile phase for buffer and acetonitrile was 53:47 % (v/v). The 230 nm wavelength was used to record chromatograms. The parameters like linear regression, accuracy, method as well as system precision were studied for validation of method. The parameters like change in wavelength, mobile phase composition and flow rate as per ICH guidelines were studied for robustness. The validation method has been successfully applicable to analyze omeprazole and drotaverine from combined dosage form i.e. tablets.