Abstract

ANALYTICAL METHOD DEVELOPMENT FOR SIMULTANEOUS DETERMINATION OF DICLOFENAC SODIUM AND ACETAMINOPHEN IN A FORMULATION

Poornima D. Potphode and Dr. Nutan Rao*

Abstract

A simple, specific, accurate and precise reverse phase high performance liquid chromatographic method was developed and validated for the estimation of Diclofenac Sodium and Acetaminophen in a formulation. An Hypersil, Octadecylsilane, 5μm column having 250 x 4.6mm internal diameter in isocratic mode with mobile phase containing Methanol: Water: Acetonitrile: Glacial Acetic Acid in the ratio of 600:250:150:10 (v/v/v) was used. The flow rate was 1.0ml/min and effluents were monitored at 281nm. The retention time for Diclofenac Sodium and Acetaminophen was 9.461min and 2.782min simultaneously. The method was validated for limit of detection, limit of quantification, robustness, linearity, accuracy, precision, and specificity. Limit of detection and limit of quantification were found to be 7.05 to 13.09 mcg/ml and 45.37 to 84.2 mcg/ml respectively and recovery of Diclofenac Sodium and Acetaminophen from tablet formulation was found to be 96.8% and 100.5% respectively. The proposed method was successfully applied for the quantitative determination of Diclofenac Sodium and Acetaminophen in tablet formulation.

Keywords: Diclofenac Sodium and Acetaminophen, HPLC, Linearity, Validation, Robustness, RP-HPLC, Simultaneous estimation, Method validation, Force degradation.