Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF NAPROXEN USING HPLC

Shah Alam, Prem Prasad and Sanjay Kumar Kushwaha*

Abstract

The nonsteroidal anti-inflammatory medicine (NSAID) is called naproxen. It is mostly used to alleviate pain or inflammation brought on by conditions including ankylosing spondylitis, tendonitis, gout, arthritis, or menstrual cramps. Naproxen comes in separate dosage forms with other comparable anti-inflammatory medications such as ibuprofen, pentoprazole, esomeprazole, ranitidine, sumatriptan and ibuprofen. For the quantification of naproxen in pharmaceutical dosage forms, a straightforward, sensitive, and accurate reversed phase high performance liquid chromatography (RP-HPLC) approach has been devised. Sodium hydroxide was used to modify the pH of dibasic sodium phosphate buffer (Na2HPO4), which was used as the mobile phase in the method's developmenA siand acetonitrile in a ratio of 70:30 (v/v) was placed at room temperature over a C-18 column (250 x 4.6 mm, 5μm, Phenomenex Inc.). The UV detector at 225 nm was used to track the column cleaning process, and the flow rate was set at 0.7 ml/min. The fine, perceptive, and accurate. Naproxen had a retention time of 4.8 ± 0.1 minutes. The recovery was found to be >97%, indicating that the methodology is accurate. The newly developed method's inter-day and intra-day precision fell below the maximum permissible level (RSD% < 2.0) as per ICH, USP, and FDA recommendations. .. The technique produced a linear response with a 0.9991 correlation coefficient (r2). As a result, the technique was discovered to be precise, repeatable, sensitive, and time-efficient, and it can be effectively used for routine analysis of naproxen in pharmaceutical formulas.

Keywords: HPLC validation, and naproxen.