A Simple and Validated Reverse Phase HPLC Methodfor the Determination of Rabeprazole inPharmaceutical Dosage Forms

Uma Mahesh Karra,Sanjeeva Yarkala

doi:10.1155/2010/412194

Abstract

A simple and rapid reverse phase high performance liquid chromatography (RP‐HPLC) method was developed and validated for quantitative determination of rabeprazole in bulk drug samples and formulations. Rabeprazole was analyzed by using reverse phase LC‐GC column (Inertsil ODS, 4.6 mm x 25 cm, 5 microns), with mobile phase consisting of methanol: water (78:22 v/v). The flow rate was set 1.0 mL/min and analysis was performed at wavelength 288 nm using Photo Diode Array (PDA) detector at ambient temperature. The method was validated and stability studies were conducted under different conditions. The retention time for rabeprazole was around 4.12 minutes. The calibration curves were linear (r≥0.9998) over a concentration range from 20.0 to 80.0 μg/mL. Limit of detection (LOD) and Limit of quantitation (LOQ) were 8 ng/mL and 24 ng/mL respectively. The developed method was successfully applied to estimate the amount of rabeprazole in tablet formulations.

Highlights

Rabeprazole is a substituted benzimidazole that inhibits gastric acid secretion and primarily used in the treatment of Ulcerative Gastroesophageal Reflux Disease (GERD)
Rabeprazole belongs to a class of antisecretary compounds that suppress gastric acid secretion by inhibiting the gastric H+, K+ATPase at the secretary surface of the gastric parietal cell
A volume of 5.0 mL of this solution was pipetted to another 50 mL volumetric flask, diluted to volume with mobile phase and mixed and 20 μL of this solution was injected into the HPLC system

Summary

Introduction

Rabeprazole is a substituted benzimidazole that inhibits gastric acid secretion and primarily used in the treatment of Ulcerative Gastroesophageal Reflux Disease (GERD). No validated HPLC methods for quantitative determination of rabeprazole in bulk drug samples and formulations were reported till date with chromatographic method discussed in this study. The stock solution was prepared by dissolving accurately weighed quantity of 10 mg of the drug in 10 mL of deionised mobile phase (final concentration, 1 mg/mL). 20 mg of rabeprazole, was transferred to a 50 mL volumetric flask, diluted with mobile phase to volume and mixed. A volume of 5.0 mL of this solution was pipetted to another 50 mL volumetric flask, diluted to volume with mobile phase and mixed (final Concentration of 0.04 mg/mL) and 20 μL of this solution was injected into the HPLC system

Method validation

Method development and optimization

Alkaline Degradation

Conclusion