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Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF PERINDOPRIL AND INDAPAMIDE IN MARKETED FORMULATION

Shivam Arya*1, Avinash K Kondalkar1, Munesh Singh Bhadouria1, Sapna Avinash Kondalkar2, Jogendra Singh1, Muraree Lal1

1Sun Institute of Pharmaceutical Education & Research (SIPER), Lahar (M.P.)
2Regional Ayurveda Research Institute (RARI), Gwalior (M.P.)

ABSTRACT

This study focuses on the development and validation of a reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of perindopril and indapamide in a marketed formulation. Perindopril is an angiotensin-converting enzyme (ACE) inhibitor, while indapamide is a thiazide-like diuretic. Both drugs are commonly used in combination for the treatment of hypertension. The RP-HPLC method was developed using a C18 column and a mobile phase consisting of a mixture of acetonitrile and methanol in a isocratic elution mode. The detection wavelength was set at 254nm, and the flow rate was optimized to achieve efficient separation and quantification of both drugs. The developed method was validated according to the International Conference on Harmonization (ICH) guidelines for various parameters such as linearity, precision, accuracy, specificity, robustness, and system suitability. The method demonstrated good linearity over the concentration range of the analytes in the formulation. The precision and accuracy were within acceptable limits, indicating the reproducibility and reliability of the method. The specificity of the method was confirmed by analyzing the sample containing the marketed formulation, ensuring that the peaks of interest were well-resolved from any interfering substances. The robustness of the method was evaluated by making deliberate changes in chromatographic conditions, and the results demonstrated the method's ability to provide consistent and reliable results.

Keywords: Perindopril, Indapamide, Method development, HPLC, Validation


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