Validated Rp-hplc Method for Simultaneous Quantification of Cinitapride and Omeprazole in Combined Tablet Dosage Form

Author(s)	Syeda Kulsum, AROOJ FATIMA FAROOQUI, AMENA BASHARATH, RIZWANA AFREEN, ZAINAB NOOREEN, ZONA FATIMA, SARWATH REHANA
Country	India
Abstract	A rapid and precise reverse-phase high-performance liquid chromatographic method has been developed and validated for the simultaneous estimation of Cinitapride and Omeprazole, in pure form as well as in tablet dosage form. Chromatography was carried out on a Hypersil C18 (4.6 × 150 mm, 5 µm) column using a mixture of acetonitrile:water:methanol (60:20:20 v/v) as the mobile phase at a flow rate of 1.0 mL/min, with detection at 230 nm. The retention times of Cinitapride and Omeprazole were 2.8 and 3.8 ± 0.02 min, respectively. The method produced linear responses in the concentration range of 10–50 µg/mL for Cinitapride and 66.6–330 µg/mL for Omeprazole. The method precision for the determination of assay was below 2.0% RSD. The method is suitable for the quality control of bulk and pharmaceutical formulations.
Keywords	Cinitapride; Omeprazole; RP-HPLC; method validation; ICH guidelines; tablet dosage form
Field	Medical / Pharmacy
Published In	Volume 8, Issue 5, September-October 2026
Published On	2026-10-18
DOI	https://doi.org/10.36948/ijfmr.2026.v08i05.89546

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