Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF NAPROXEN AND DOMPERIDONE IN ITS PHARMACEUTICAL DOSAGE FORM

Jatinkumar D. Raja*, Bhumi Patel, Jaymin Patel, Dr. Vinay Darji, Ketul Prajapati, Rohit Gajera

ABSTRACT

A simple, rapid, precise & accurate stability indicating RP-HPLC method for simultaneous estimation of Naproxen and Domperidone has been developed and validated. To optimize mobile phase, various combination of buffer and organic solvent were used on Hypersil BDS Column C18 (25 cm × 0.46 cm, 5 μm) column. Mobile phase contains mixture of Buffer (pH 3.5) & methanol in ratio of 60:40% v/v was selected at flow rate (1.0 mL/min) for developing method and peaks with good shape and resolution were found short retention time, baseline stability and minimum noise. The retention time of Naproxen and Domperidone was found to be 4.060 and 5.850 min respectively. The method has been validated for linearity, accuracy, LOD, LOQ, robustness and precision. Linearity observed for range of 25-75 μg/mL for Naproxen and 1-3 μg/mL for Domperidone. The high percentage of recovery indicates the proposed method is highly accurate. Forced degradation study was carried out. The degradation products were well resolved from the pure drug with significant differences in their retention time values.

Keywords: Naproxen, Domperidone, RP-HPLC, Validation, Stability.