Analytical Method Development and Validation for Simultaneous Estimation of Naproxen and Esomeprazole in Pharmaceutical Dosage Forms

Abstract

Introduction: An accurate, specific and precise reverse phase UV spectrophotometric method was developed for the simultaneous estimation of Naproxen and Esomeprazole in tablet dosage form. Naproxen and Esomeprazole tablets were used to relieve the spondylitis, osteoarthritis and rheumatoid arthritis in adults’ juvenile idiopathic arthritis in children. Methods: Simple and accurate UV spectroscopic method was developed using Naproxen and Esomeprazole tablet and results were tabulated. Results and Discussion: The optimum conditions were established for the analysis of the drug. The maximum wavelength of Naproxen (λmax) was found to be 231nm and for Esomeprazole was 301nm respectively. The linearity of the method developed was in the range 10-50 μg/ml for Naproxen and 30-70 μg/ml for Esomeprazole. Calibration curves for Naproxen and Esomeprazole showed a linear relationship among the absorbance and concentration. The line equation observed for Naproxen is Y= 0.0374X + 0.0805 with r2 of 0.9936 and for Esomeprazole drug was 0.0377 X+0.0576 with R2 of 0.9962 . Validation parameters were performed as per ICH guidelines for all validation parameters like linearity, accuracy, precision, LOD and LOQ. The results of LOD and LOQ were found to be within the range. Conclusion: The proposed method for Naproxen and Esomeprazole was simple, yet sensitive and precise for repeated analysis of Naproxen and esomeprazole in bulk and tablet formulations.