Method development and validation for estimation of Naproxen in bulk samples as well as in tablet dosage forms by using RP-HPLC

Abstract

Purpose: A simple, precise, accurate, rapid and economical reverse phase high-pressure liquid chromatographic method has been developed as per ICH norms for the estimation of Naproxen from pharmaceutical formulation.
Methods: The method was carried out on a Kromosil-C18 ODS column (150 mm X 4.6 mm; 5 μ) with a mobile phase consists of ammonium acetate buffer (adjusted to pH 4.0 with 1 % Triethyl amine): methanol (40:60 v/v) and filtered through a 0.45 μ cellulose nitrate filters. The flow rate was maintained in isocratic mode at 1.0 mL/min. The detection was carried out at 210 nm. The run time was 7.0 min.
Results: The retention time was 3.063 min for Naproxen. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantification and solution stability.
Conclusion: The proposed method was adequate sensitive, reproducible, and specific for the determination of Naproxen in bulk as well as in tablet dosage forms.