Synthesis, and A Novel High-Performance Liquid Chromatographic Method for the Determination of Naproxen in Pharmaceutical Formulations

Abstract

We established a simple and accurate optimised RP-HPLC method for quantitative estimation of naproxen in pharmaceutical dosage forms. The method was developed using an Agilent SCX-300 column (250 × 4.6 mm, 5 µm) at room temperature. The mobile phase consisted of methanol, water, and acetonitrile in a volumetric ratio of 60:20:20, supplemented with 7 mM docusate sodium and perchloric acid, adjusted to a pH of 3.We calibrated a UV detector at 254 nm to detect column washing, and adjusted the flow rate to one millilitre per minute to ensure proper column cleaning. The naproxen retention time in this experiment was 3.4 ± 0.1 minutes; this was considered good. The fact that the recovery rate exceeded 100% in this case confirmed the accuracy of the technique. But the new technique failed to meet the high degrees of precision stipulated by the ICH and the FDA; it had an RSD percent of 2.0. The technique yielded a linear response, with a correlation coefficient of one. Technological advancements that demonstrate precise analysis of naproxen in trademarked prisms are credible, repeatable, delicate, and time-efficient, thereby enabling routine analysis of naproxen in pharmaceutical formulations.