Development and validation of reverse phase-high performance liquid chromatographic method for simultaneous estimation of naproxen sodium and esomeprazole magnesium trihydrate

Abstract

Background: Naproxen sodium (NAP) is a non steroidal anti-inflammatory drug and Esomeprazole magnesium trihydrate (ESO) is a proton pump inhibitor. Aim: A high performance liquid chromatographic method was developed and validated for the quantitative determination of naproxen (NAP) sodium and esomeprazole (ESO) magnesium trihydrate. The different analytical parameters such as linearity, precision, accuracy, limit of detection and limit of quantification were determined according to the International conference harmonization (ICH) Q2B guidelines. Materials: Chromatography was carried out by isocratic technique on a reversed phase C18 base deactivated silanol hypersil column with mobile phase and optimized depending upon the polarity of the molecules. Results: The calibration curves were linear (r2 > 0.9997) over the concentrations 20-120 μg/mL for NAP sodium and 0.8-4.8 μg/mL for ESO magnesium trihydrate. The method was accurate and precise with recoveries in the range of 99.48-99.98% for the two drugs and relative standard deviation less than 2%. No chromatographic interferences from the tablet excipients were found. Conclusion: The proposed method was highly sensitive, precise and accurate. Hence the method was successfully applied for the reliable quantification of active pharmaceutical ingredients content in house prepared tablet formulation of NAP sodium and EOS magnesium trihydrate.