Paper Contents
Abstract
The development and validation of a Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) method for the determination of omeprazole and cinitapride in bulk and pharmaceutical formulations are detailed in this study. The RP-HPLC analysis was performed using a Waters HPLC system equipped with an auto sampler and a PDA Detector 996 model. Chromatographic separation was achieved with a Hypersil C18 column (4.6 250 mm, 5 m particle size) at a column temperature of 35C. The mobile phase consisted of methanol and water in a 80:20 (vv) ratio. The flow rate was set at 0.8 mLmin, and detection was carried out at a wavelength of 250 nm. An injection volume of 10 L was used, and the total run time for each analysis was 6 minutes.The method was rigorously validated in accordance with ICH guidelines, assessing key parameters such as specificity, linearity, precision, accuracy, and robustness. The RP-HPLC method demonstrated excellent resolution and peak symmetry for both omeprazole and cinitapride, with high accuracy and precision. The validated method provides a reliable and efficient analytical tool for the simultaneous quantification of omeprazole and cinitapride in bulk drug substances and pharmaceutical formulations, ensuring compliance with quality control standards and supporting the consistent quality of pharmaceutical products.
Copyright
Copyright © 2024 N Poojitha. This is an open access article distributed under the Creative Commons Attribution License.
