Abstract

STABILITY INDICATING SIMULTANEOUS ESTIMATION OF ASSAY METHOD FOR ESOMEPRAZOLE AND NAPROXEN IN BULK AS WELL AS IN PHARMACEUTICAL FORMULATION BY USING RP-HPLC

*S. Ashutosh Kumar¹, Manidipa Debnath², Dr. J.V.L.N.Seshagiri Rao³

ABSTRACT

Esomeprazole is used to treat gastro esophageal reflux disease. Naproxen is a Non steroidal anti inflammatory drug (NSAID) used in the treatment of pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps. A simple, precise, cost effective and stability indicating RPHPLC method was developed and validated for the determination of both Esomeprazole and Naproxen in Pharmaceutical compositions. Separation of Esomeprazole and Naproxen from its potentional degradants were achieved within a shorter run time with required resolution, accuracy and precision thus enabling the utility of the method for routine analysis The chromatographic separation was achieved on a Symmetry C18 (4.6 x 150mm, 5m, Make: XTerra) using a mobile phase consist of a mixture of phosphate buffer (pH 3) and Acetonitrile [60: 40] The flow rate of mobile phase was maintained 1.0 mL per minute. The wavelength chosen for detection was 285 nm. The retention times of Esomeprazole and Naproxen peaks were around 2.105 and 3.555 mins respectively. The Accuracy was calculated for 50%, 100% and 150% and the % recovery was found 98.0%-100.4%. The method was found to be linear over the range of 5ppm to 9ppm per mL for Esomeprazole 125ppm to 225ppm per mL for Naproxen. The drug content formulations were quantified by using the proposed analytical method. The proposed method can be successfully applied in the quality control of bulk and pharmaceutical dosage forms. The method was also applied for the determination of Esomeprazole and Naproxen in the presence of their degradation products formed under variety of stress conditions. The method was applied for the determination of Esomeprazole and Naproxen in the presence of their degradation products formed under the variety of stress conditions. The bulk active pharmaceutical ingredient was subjected to thermal, photolytic, hydrolytic (acidic and basic) and oxidative stress conditions and stressed samples were analyzed by the proposed method. The validation of method was carried out utilizing International Conference on Harmonization (ICH) guidelines. The described High Performance Liquid Chromatography method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form. Validation was performed as ICH guidelines for linearity, accuracy, precision, LOD and LOQ. The proposed method was successfully applied for the quantitative determination of Esomeprazole and Naproxen in tablet dosage form.

Keywords: Esomeprazole magnesium, Naproxen, HPLC, LOD, LOQ and Simultaneous Estimation.