Development and validation of RP-HPLC method for simultaneous analysis of Perindopril and Indapamide in bulk and combined pharmaceutical dosage form

摘要

A simple, rapid and sensitive isocratic RP-HPLC method was developed for the simultaneous estimation of Perindopril and Indapamide present in bulk and their pharmaceutical formulations using Thermo hypersil BDS C18 (250 x 4.6 mm i.d, packed with 5 u particle size) column at ambient temperature in an isocratic mode with mobile phase comprising KH2PO4 buffer adjusted to pH 3.5: Methanol in the ratio of 80:20 (% v/v). The flow rate was 0.8 ml/ min and effluent was monitored at 215 nm. The retention time were found to be 3.54 min for Perindopril and 4.10 min for Indapamide. The assay exhibited a linear concentration range of 160-480 μg/ml for Perindopril and 50-150 μg/ml for Indapamide with a correlation coefficient of 0.9992 for Perindopril and 0.9999 for Indapamide respectively. Recovery was found to be 99.92 % ±0.42 for Perindopril and 99.75 % ± 0.28 for Indapamide respectively. The proposed method was statistically developed and validated as per ICH guidelines and can be applied for routine quality control analysis of Perindopril and Indapamide in Pharmaceutical dosage forms.