RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION AND FORCED DEGRADATION STUDIES OF NAPROXEN AND ESOMEPRAZOLE MAGNESIUM IN DELAYED RELEASE DOSAGE FORM

Abstract

A simple stability indicating reverse phase high performance liquid chromatography method was developed and validated for simultaneous estimation 
of naproxen and esomeprazole magnesium in combined delayed release dosage form 500/20 mg, 375/20 mg, using a single unit of tablet. 
Chromatographic separation was achieved with Agilent's high performance liquid chromatography and Xterra RP-18 column, with the mobile phase-1 
of perchlorate buffer (pH 8.7): acetonitrile methanol (700:200:100, v/v/v) and mobile phase-2 of per chlorate buffer (pH 8.7): acetonitrile (700:300, 
v/v) by gradient elution technique. The flow rate was maintained at 1.5 ml/min and the detection wavelength was 305 nm. Naproxen and esomeprazole 
were eluted at 3.3 min and 6.1 min respectively using the developed method. Analytical method validation was performed according to International 
Conference on Harmonization Q2 (R1) guidelines. The method was linear in the range of 60-1500 μg/ml for naproxen and 2-60 μg/ml for esomeprazole, 
with r2 value of 0.9996 and 0.9997 respectively. The sample recoveries observed were 100.38-101.39% and 99.67-99.94% respectively for naproxen 
and esomeprazole magnesium, which confirm the non-interference of formulation additives in the estimation. The forced degradation studies were 
carried out and the stressed samples were analyzed using the developed method. The purity angle of the peak was observed lesser than the threshold 
angle, which confirms the non-interference from degradants in quantitating naproxen and esomeprazole in bulk and marketed formulation