Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DICLOFENAC POTASSIUM AND FAMOTIDINE IN ITS PHARMACEUTICAL DOSAGE FORM

Pooja P. Shah*, Bhumi Patel, Jaymin Patel, Dr. Vinay Darji, Ketul Prajapati, Jatinkumar D. Raja

ABSTRACT

A Simple, Rapid, Economical, Precise and Accurate stability indicating RP-HPLC method for simultaneous estimation of Diclofenac Potassium and Famotidine in their combined dosage form has been developed. A reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Diclofenac Potassium and Famotidine in their combined dosage form has been developed. The separation was achieved by LC- 20 AT C18 (250mm x 4.6 mm x 2.6 μm) column and Water: Methanol (70:30%v/v) as Mobile Phase, at a flow rate of 1 mL/min. Detection was carried out at 263 nm. Retention time of Diclofenac Potassium and Famotidine were found to be 3.300 min and 4.740 min, respectively. The method has been validated for Specificity, Linearity, Accuracy, Precision, LOD, LOQ and Robustness. Linearity observed for Diclofenac Potassium 12.5-37.5 μg/mL and for Famotidine 5-15 μg/mL. Developed method was found to be Accurate, Precise and Rapid for simultaneous estimation of Diclofenac Potassium and Famotidine in their combined dosage form. The drug was subjected to stress condition of Hydrolysis, Oxidation, Photolysis and Thermal degradation, Forced degradation study was carried out. The degradation products were well resolved from the pure drug with significant differences in their retention time values. The proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial combined dosage form.

Keywords: Diclofenac Potassium, Famotidine, Stability indicating RP-HPLC Method, Validation.