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

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.