STABILITY INDICATING ISOCRATIC RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR INDAPAMIDE AND PERINDOPRIL ERBUMINE IN PURE AND ITS COMBINED TABLET DOSAGE FORM

A reverse phase liquid chromatography method (RP-HPLC) was developed to estimate the amount of Indapmide and Perindopril in bulk and its pharmaceutical formulations. A Waters Alliance HPLC system equipped with auto sampler, UV-Visible detector and YMC Column (150 x 4.6mm, 3µ particle size) were used for the quantification of the drugs. Separation was carried out by using potassium dihydrogen phosphate buffer of pH 2.5 and acetonitrile in the ratio 60:40 v/v as mobile phase at a flow rate of 1 ml/min and the detection was carried out at a wavelength of 230 nm. The retention time, tailing factor and USP theoretical plates were found to be 2.5 min., 1.38 and 2551 for Indapamide and 4.18., 1.75 and 2778 for Perindopril respectively. The area of the peak was proportional to the concentration of the drug in the range 15-35, 48-112 μg/ml of Indapmide and Perindopril. The values of LOD and LOQ for Indapmide and Perindopril were found to be 0.07, 27.87 and 0.23, 84.47 μg/ml respectively. The mean recoveries of the substances were found to be 99.23 and 100.28 %. The bulk active pharmaceutical ingredient was subjected to thermal, hydrolytic (acidic and basic) and oxidative stress conditions and stressed samples were analyzed by the proposed method. The developed method was simple, specific, sensitive, rapid, and economical and can be used for simultaneous estimation of Indapamide and Perindopril in bulk and their combined dosage form for routine analysis and stability studies.