Development and validation of an RP-HPLC method for simultaneous analysis of drotaverine and omeprazole in a tablet dosage form

Abstract

Summary A simple, rapid reversed-phase high-performance liquid chromatographic method has been developed and validated for simultaneous estimation of drotaverine and omeprazole in a tablet dosage form. A C18 column was used with a 60:40 (v/v) mixture of methanol and ammonium acetate (0.1 m, pH 5, adjusted with orthophosphoric acid) as mobile phase at a flow rate of 1.5 mL min−1. UV detection was performed at 319 nm. The method was validated for accuracy, precision, linearity, specificity and sensitivity in accordance with International Conference on Harmonisation guidelines. The method was successfully used for quantitative analysis of Ranipas-DV tablets. Total run time was 10 min, drotaverine and omeprazole were eluted with retention times of 7.969 and 6.538 min respectively. Validation revealed that the method is specific, accurate, precise, reliable and reproducible. Calibration plots were linear over the concentration ranges 5–40 μg mL−1 for drotaverine and 5–50 μg mL−1 for omeprazole, respectively. L...