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Estimation of Drotaverine and Omeprazole in Combined Dosage form by Spectrophotometric Methods
Two simple, precise, accurate and reproducible spectrophotometric methods have been developed for the simultaneous estimation of Drotaverine HCl (DRO) and Omeprazole (OME) in combined tablet dosage form. The first method is the Area under curve method, the sampling wavelength range selected for estimation of drotaverine and omeprazole are 227.5-231.5 nm and 300.0-304.0 nm respectively with linearity in the concentration ranges of 4-24 mg /ml and 1-6 mg/ml respectively. Second method is based on two wavelength calculations, wavelengths selected for estimation of drotaverine were 300.0 nm and 304.0 nm and for Omeprazole were 279.5 nm and 290.5 nm over the concentration ranges of 4-16 mg/ml and 1-6 mg/ ml for drotaverine and omeprazole respectively. The results of the analysis were validated statistically and recovery studies were carried out as per ICH guidelines.
Keywords
Drotaverine, Omeprazole, Area under Curve Method, Two-Wavelength Method, ICH Guidelines.
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