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New Stability Indicating Method for the Simultaneous Determination of Impurities Present in Candesartan Cilexetil and Hydrochlorothiazide Tablets by Ultra Performance Liquid Chromatography with Photo Diode Array Detector


M. V. V. N. Murali Krishna, Sumathi V Rao, N. V. S. Venugopal, Bhaskara P. V. Mantena

Article (PDF)

Keywords

RP-UPLC, candesartan cilexetil, hydrochlorothiazide, acquity UPLC HSS T3, ICH

Abstract

A simple, rapid Reverse phase – Ultra Performance liquid chromatography (RP-UPLC) method was developed and validated for the simultaneous determination of thirteen known potential impurities present in Candesartan cilexetil and Hydrochlorothiazide fixed dose combination drug product. Chromatographic separation attained using 0.1% Perchloric acid in water and acetonitrile as Mobile phase-A and B respectively. The components were efficiently separated in Acquity UPLC HSS T3, 100 mm x 2.1 mm with 1.8 m particle size column. Flow gradient elution mode with initial flow rate of 0.5 mL.min-1 followed by 0.6 mL.min-1 was used. The impurities were quantified at a working wavelength of 220 nm. The developed method was validated as per International Conference on Harmonization (ICH) recommendations for specificity, linearity, precision, ruggedness, accuracy, sensitivity (Limit of Detection & Limit of Quantitation) and robustness. The present stability indicating method is having shorter run time which is helpful for fast analysis of samples during quality control testing with reduced solvent consumption in a cost and time effective approach.