RP-HPLC Method Development and Validation for Simultaneous Estimation of Ketoprofen and Omeprazole in Bulk Medication and Formulations

The aim of this study was to develop and validate a reliable and efficient analytical method for the simultaneous estimation of ketoprofen and omeprazole in dosage forms. Ketoprofen, a nonsteroidal anti-inflammatory drug (NSAID), and omeprazole, a proton pump inhibitor, are frequently co-administered for their complementary therapeutic effects in the treatment of gastrointestinal disorders. A novel high-performance liquid chromatography (HPLC) method was developed to enable the simultaneous quantification of both drugs. The method utilized a mobile phase composed of a 50:50 mixture of acetonitrile and methanol, with detection wavelengths set at 255 nm for ketoprofen and 302 nm for omeprazole. The linearity range for ketoprofen and omeprazole was determined to be 20–120 µg/mL and 50–300 µg/mL, respectively, with high correlation coefficients of 0.9997 and 0.9996. The precision of the method was confirmed with %RSD values below 2 for both drugs, demonstrating excellent reproducibility. In compliance with ICH Q2 (R1) guidelines, intra-day precision was found to be 0.53% for ketoprofen and 0.54% for omeprazole, while inter-day precision was 1.03% and 1.18%, respectively. The developed method offers a straightforward, rapid, and cost-effective solution for the simultaneous estimation of ketoprofen and omeprazole, with significant potential for routine analysis and quality control in pharmaceutical applications. This validated approach is suitable for both individual drug formulations and combination therapies, ensuring accurate and reliable assessments for quality assurance.