DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF CINITAPRIDE HYDROGEN TARTARATE AND OMEPRAZOLE IN CAPSULE

摘要

A reverse phase (RP-HPLC) method has been developed and validated for the simultaneous determination of cinitapride hydrogen tartarate and omeprazole from its pharmaceutical capsule dosage form. The determination was carried out on a Phenomenex, C18 (250 mm x 4.6 mm, 5 mc) column using a mobile phase of acetonitrile: methanol: water (60:30:10, V/V/V). The flow rate was 1.0 mL min~(-1) and quantification was achieved with PDA detector at 265 nm. The retention time for cinitapride hydrogen tartarate and omeprazole was found to be 8.46 and 3.16 min, respectively. The linearity for both the drugs was obtained in the concentration range of 0.1-3.0 mcg mL~(-1) with mean accuracies 100.59 ± 0.95 and 100.77 ± 0.78 for cinitapride hydrogen tartarate and omeprazole, respectively. The method was successfully applied to pharmaceutical formulation because no chromatographic interferences from capsule excipients were found. The results of analysis have been validated statistically and by recovery studies. Developed method was found to be suitable for the simultaneous estimation of cinitapride hydrogen tartarate and omeprazole in capsule.