DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR DETERMINATION OF PERINDOPRIL ERBUMINE

Abstract

Perindopril erbumine is one of the newly used non peptide Angiotensin II receptor antagonist, and is used for the treatment of patients with hypertension and symptomatic heart failure. An approach for forced degradation was successfully applied for the development of Stability indicating HPTLC method for determination of Perindopril erbumine in the presence of its degradation products. The method was based on the separation of Perindopril from its degradation product on plates precoated with silica gel 60 F_. The mobile phase used was Dichloromethane : Methanol : Glacial acetic acid in the ratio of 9:0.8:0.1 v/v/v. The drug showed considerable absorbance at 215 nm. Stress testing of Perindopril erbumine was carried out according to the International Conference on Harmonization (ICH) guideline Q1A (R2). The drug was subjected to acid hydrolysis, base hydrolysis, neutral hydrolysis, oxidation, thermal degradation and photostability studies to apply stress conditions. There was no interference between the drug peak and that of the degradation product; therefore the method was specific for determination of Perindopril erbumine in presence of the degradation product. The method was successfully validated according to ICH Harmonized Tripartite guidelines. The Linearity of the proposed method was found to be in the concentration range of 1 5 $\mu$ g/band.