Development and Validation of UV Spectrophotometric Method for the Estimation of Naproxen in Bulk and Formulation

This study focuses on the development and validation by a UV spectrophotometric method for the estimation of Naproxen in bulk and tablet formulation. Naproxen is a Nonsteroidal Anti-Inflammatory Drug (NSAIDs). It is mostly used to treat pain or inflammation caused by conditions such as arthritis, gout, tendinitis or menstrual cramps. Naproxen is available in isolated dose with various similar anti-inflammatory drugs, i.e.; Esomeprazole, Pantoprazole, Paracetamol, Ranitidine, Sumatriptan and Ibuprofen. The analytical method was optimized using a ratio of two solvents to ensure accuracy and reproducibility. Validation of the API (Active Pharmaceutical Ingredient) was performed in accordance with ICH (International Council for Harmonisation) guidelines, evaluating key parameters such as specificity, linearity, precision, accuracy, and robustness. The method demonstrated a high degree of reliability for routine quality control analysis. Additionally, the assay of Naproxen tablets using the developed method exhibited consistent and precise results, confirming its suitability for pharmaceutical applications. This validated method offers a simple, cost-effective, and efficient approach for the quantitative analysis of Naproxen.