ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF NAPROXEN SODIUM BY UV SPECTROSCOPY

K. CHAITANYA PRASAD M

doi:10.70604/

Authors

M.K. Chaitanya Prasad Associate Professor, Department of Pharmaceutical Analysis, St .Ann’s college of Pharmacy, Chirala.

Abstract

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 condition such as arthritis, gout, tendinitis or menstrual cramps. Naproxen is available in isolated dose with various similar anti-inflammatory drug, 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 Harmonization) 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.

Keywords:

Naproxen, UV Spectrophotometry, Method Validation, Pharmaceutical Analysis, Tablet Formulation,, ICH Guidelines

DOI

https://doi.org/10.70604/

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