ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF OMEPRAZOLE AND CINITAPRIDE IN COMBINED DOSAGE FORM BY RP-HPLC
A simple, precise and accurate reverse phase liquid chromatographic method has been developed for the simultaneous estimation of Omeprazole and Cinitapride in tablet formulations. The chromatographic separation was achieved on BDSHypersil C18 (150mmx4.6mm, 5µ) analytical column. A mixture of Phosphate Buffer (pH 6.8): methanol was used in the ratio (40:60).was used as the mobile phase at the flow rate of 1.0mL/min and detector wavelength at 210nm (Isobestic Point). The retention time of Omeprazole and Cinitapride were found to be 3.2min and 4.1min respectively. The validation of the proposed method was carried out for linearity, accuracy, recovery, precision, limit of detection, limit of quantification and robustness. The linear dynamic ranges were 10-30 μg/mL for Omeprazole and 1.5-4.5 μg/mL For Cinitapride. Limit of detection and quantification for Omeprazole were 2.03μg/mL and 6.77μg/mL and Cinitapride 0.19μg/mL and 0.98μg/mL respectively. The developed method can be used for routine quality control analysis of titled drugs in combination of tablet formulation