SIMULTANEOUS ESTIMATION OF ESOMEPRAZOLE AND NAPROXEN IN BULK AS WELL AS IN PHARMACEUTICAL FORMULATIONS BY USING RP-HPLC

SIMULTANEOUS ESTIMATION OF ESOMEPRAZOLE AND NAPROXEN IN BULK AS WELL AS IN PHARMACEUTICAL FORMULATIONS BY USING RP-HPLC

S. Ashutosh Kumar*¹, Manidipa Debnath ² and J.V.L.N. Seshagiri Rao ³

Department of Pharmaceutical Analysis ¹, Department of Pharmaceutics ², A.K.R.G College of Pharmacy, Nallajerla, West Godavari, 534112, Andhra Pradesh, India

Department of Pharmaceutical Analysis, Yalamarty College of Pharmacy ³, Tarluwada Visakhapatnam, 530052, Andhra Pradesh, India

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 RP-HPLC method was developed and validated for the determination of both Esomeprazole and Naproxen in Pharmaceutical compositions. The chromatographic separation was achieved on a Symmetry C18 (4.6 x 150mm, 5mm, 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 to be 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 proposed method was validated as per the ICH and USP guidelines.

Esomeprazole magnesium, Naproxen, HPLC and Validation

INTRODUCTION:Esomeprazole magnesium [bis (5-methoxy-2-[(S)-[(4-methoxy-3, 5- dimethyl-2-pyridinyl) methyl] sulfinyl]-1-H-benzimidazole-1-yl)magnesium salt] is a compound that inhibits gastric acid secretion. Esomeprazole (fig. 1) is cost effective in the treatment of gastric oesophageal reflux diseases. Esomeprazole is the S-isomer of Omeprazole, the first single optical isomer proton pump inhibitor, generally provides better acid control than racemic counterpart and has a favorable pharmacokinetic profile relative to Omeprazole.

Naproxen [(S)-6-methoxy-α-methyl-2-naphthalene acetic acid], is a non-steroidal anti-inflammatory drug (NSAID) commonly used for the reduction of moderate to severe pain, fever, inflammation and stiffness (fig. 2). It works by inhibiting both the COX-1 and COX-2 enzymes.

Like other NSAIDs, combination of both Esomeprazole magnesium and Naproxen is used for the treatment and control of signs and symptoms of osteoarthritis, rheumatoid arthrit