Novel Development of RP-HPLC Method to Quantify Amoxicillin, Omeprazole and Rifabutin in Combination

Abstract

Objectives: Helicobacter pylori infections are liable for most of the ulcers in the stomach and small intestinal. Talicia capsules was approved to be prescribed for the Helicobacter pylori infections. These capsules have combination of amoxicillin (ACN), omeprazole (OPE) and rifabutin (RFN). In this present study, for the first time, we developed a stability demonstrating RP-HPLC methodology to quantify ACN, OPE and RFN simultaneously. Methods: Assay of this combination was done with Thermo C18 stationary phase column using the mobile phase solvent system of 0.1M KH2PO4 buffer (3.5 pH): acetonitrile. Degradation tests were done on ACN, RFN and OPE solution by applying five different conditions, i.e. 0.1N HCl, 0.1N NaOH, 30% H2O2, 105°C and sun light. Results: Retention times of ACN, RFN and OPE were 2.539 min, 3.863 and 5.423 min, respectively. Method linearity scope was ranged from 125 – 375 μg/ml for ACN, 5 – 15 μg/ml for OPE and 6.25 – 18.75 μg/ml for RFN. The accuracy was computed in the range of 98.13–101.07% and the precision was between 0.282% and 0.569% relative standard deviation for three drugs. The method can effectively separate the degradation products from ACN, RFN and OPE. Conclusion: The results demonstrated that this method can be employed to quantify ACN, OPE and RFN simultaneously in presence of impurities produced during degradation investigation.