ISSN : 2663-2187

Development and Validation of RP-HPLC Method for Estimation of Nebivolol and Indapamide in Bulk Drug and Formulation

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Rajendra D. Dighe, Chandraprakash R. Deore, Sadhana B. Mahajan, Vinod A. Bairagi
ยป doi: 10.48047/AFJBS.6.13.2024.444-462

Abstract

The research presents the development and validation of a robust RP-HPLC (Reversed-Phase High-Performance Liquid Chromatography) method for the simultaneous estimation of Indapamide and Nebivolol in pharmaceutical formulations. Utilizing an Agilent system with an auto sampler, Gradient System DAD Detector, and a C18 column, the method employed a mobile phase consisting of 35% Methanol and 65% water with 0.1% TFA. The detection was performed at a wavelength of 257 nm with a flow rate of 1.1 ml/min, resulting in retention times of 5.316 minutes for Indapamide and 7.467 minutes for Nebivolol. Method validation was conducted following ICH guidelines, covering parameters such as linearity, precision, range, and robustness. The results confirmed that the method is simple, accurate, precise, economical, and replicable. This newly developed RP-HPLC method proves to be suitable for routine quality control analysis of Indapamide and Nebivolol in bulk drugs and their formulations, ensuring no interference during simultaneous determination.

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