Abstract

DEVELOPMENT OF ANALYTICAL METHOD AND IT’S VALIDATION FOR SIMULTANEOUS ESTIMATION OF OMEPRAZOLE AND DOMPERIDONE IN CAPSULE DOSAGE FORM BY REVERSED PHASE HPLC

Lipika Baro*, Dr. Partha Jyoti Gogoi, Somi Borah and Manaswini Bharadwaz

ABSTRACT

The purpose of this present work is to develop and validate a simple, linear, accurate and precise Reverse Phase High Performance Liquid Chromatography method for the simultaneous estimation of Omeprazole and Domperidone in capsule dosage form (fixed dose combination formulation). For this, the analysis was carried out by using a Reverse Phase C8 5μ column (length: 250 mm, ID: 4.0mm) as stationary phase and a mixture of Ammonium Acetate buffer pH7 and methanol in the ratio of 25:75 as mobile phase, detection wavelength was set at 282 nm, column oven temperature at 250C and flow rate at 1.5ml/min. The calibration curves were found to be linear with correlation coefficient (R2) of 0.999 for Omeprazole and 0.996 for Domperidone. Precision of the method was established as the % RSD was found less than 2%. All the validation data showed that the method can be used as a routine analytical technique for determining these two drugs simultaneously.

Keywords: chromatography, Validation, analytical technique, simultaneous estimation.