Abstract

METHOD DEVELOPMENT AND VALIDATION OF NAPROXEN SODIUM IN PHARMACEUTICAL TABLET DOSAGE FORM BY RP-HPLC

C. N. Nalini*, Koppala Rajesh and S. Amuthalakshmi

ABSTRACT

A simple, sensitive, precise and accurate method was developed and validated for naproxen sodium in pharmaceutical tablet dosage form. The method was developed using the mobile phase comprising of methanol and water in the ratio 60:40 (v/v) over C18 column (150 x 4.6 mm, 5μm, Waters Inc.). The flow rate was at 1.0 ml/min and UV detection was performed at 238 nm. The retention time was at 2.26 min of a total run time of 10 min. The method showed linear response with correlation coefficient (r2) value of 0.9983. The method was validated for accuracy, precision, specificity, and robustness, limit of detection and limit of quantitation, in accordance with ICH guidelines. The wide linearity range, sensitivity, accuracy and simple mobile phase showed that the method is suitable for routine analysis of Naproxen sodium in pharmaceutical dosage forms with high precision and accuracy.

Keywords: Naproxen sodium, Validation, RP-HPLC.