RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF OMEPRAZOLE AND CINITAPRIDE IN TABLETS

Abstract

The present work describes a simple reverse phase HPLC method for the determination of omeprazole and cinitapride from tablet formulations. The determination was carried out on a Thermo Hypersil, BDS, C-18 (250x4.6 mm, 5 micron) column using a mobile phase of 0.1 N phosphate buffer(pH 3.2): Acetonitrile (60:40). The flow rate was 1 ml/min and the runtime was 7 min. The Column temperature was 35°C and the eluent was monitored at 230 nm. The retention times of Omeprazole and Cinitapride are 3.5minutes and 5.3minutes respectively. The method was reproducible, with good resolution between Omeprazole and Cinitapride. The detector response was found to be linear in the concentration range of 50-150 µg/ml for Omeprazole and Cinitapride. The developed method was validated for specificity, system suitability, precision, linearity, accuracy, Limit of Detection, Limit of Quantification, robustness, and Stability. Recovery of Omeprazole and Cinitapride in formulations was found to be in the range of 99%, 100%, and 101% respectively. And the correlation coefficient was 0.999. Hence, it was concluded that the developed method is suitable for routine analysis of these combination due to its less analysis time.