A Simple RP-HPLC Method Development and Validation for the Simultaneous Estimation of Naproxen and Rabeprazole

Abstract

A simple, economic, selective, accurate, precise reverse phase high performance liquid chromatographic method for the simultaneous estimation of naproxen and rabeprazole sodium in pure and pharmaceutical dosage forms was developed and validated. Naproxen and rabeprazole sodium were well separated using a phenomenex ODS C18 column of dimension 4.6 mm × 250 mm, 10 µm and mobile phase comprised of sodium dihydrogen phosphate buffer (pH 7.5±0.1) and acetonitrile in the ratio of 70:30 (v/v) at the flow rate 1 mL/min and the detection was performed at 275nm. The retention time for naproxen and rabeprazole sodium were found to be 3.33 ± 0.027 and 7.61 ± 0.043 min, respectively. The developed method was validated for specificity, linearity, precision and accuracy according to ICH guidelines. The proposed method is highly specific and linear over the concentration range of 2.0-60.0 µg/mL and 1.0-30.2 µg/mL for naproxen and rabeprazole sodium, respectively. The intraday precision (% RSD) of naproxen and rabeprazole sodium was in the range of 0.39 -1.88% and 0.20 -1.51% while the interday precision ranged from 0.08 -1.34% and 0.73 -0.87%, respectively. The accuracy (in terms of recover) of the method varied from 99.4-104.2% and 98.1-100.6% for naproxen and rabeprazole sodium, respectively. The LOD and LOQ of naproxen and rabeprazole sodium were found to be 0.6 and 0.1 µg/mL and 1.7 and 0.4 µg/mL, respectively. The sample solutions were stable for at least three hours. However, the developed method was successfully applied to assay naproxen and rabeprazole sodium brands available in Bangladesh.

High Performance Liquid Chromatographic Determination of Naproxen in Prepared Pharmaceutical Dosage Form and Human Plasma and its Application to Pharmacokinetic Study

“…But there is always a need of a meaningful cost-effective method for estimation of naproxen sodium because the present methods do not provide the sensitivity [1,2,5]. The aim of the present study was to develop a simple and effective RP-HPLC method for quantification of naproxen in pharmaceutical preparations [5][6][7][8][9] as well as in spiked human plasma and animal plasma (rabbits) [7,10,11] in a very short time and to validate that method according to ICH and FDA guidelines (Food and drug administration 2012; United states Pharmacopoeia 2007; International Conference on Harmonization (ICH) 2005;). The method was successful due to its suitability and reproducibility.…”