Abstract

STABILITY INDICATING HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF LAFUTIDINE & DOMPERIDONE IN ITS DOSAGE FORMS

Prashant D. Ghode*, Dr. Sunil P. Pawar

ABSTRACT

A simple, rapid, precise, sensitive and reproducible stability indicating Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method for determination of Lafutidine and Domperidone in capsule dosage form was developed. Chromatographic separation was achieved on Zodiac C18 (250mm × 4.6 mm, 5μm) column maintained at ambient temperature eluted with mobile phase at flow rate of 1 ml/min. The mobile phase consists of o-Phosphoric Acid and Acetonitrile in the ratio 65:35% v/v was used and the determination was carried out at 215nm. The retention time for Lafutidine and Domperidone were 4.901 min and 8.274 min respectively. The linearity was found to be in
the range of 3- 9 μg/ml for Lafutidine and 9-27 μg/ml for Domperidone. The analytical method was validated as per ICH guideline for linearity, accuracy, precision, and specificity, limit of detection, limit of quantification, stability etc. and method can be extended to the analysis of Lafutidine and Domperidone in capsule formulations.

Keywords: Lafutidine, Domperidone, Estimation, HPLC, Stability Indicating.