RP-HPLC Method Development and Validation for the Simultaneous Determination of Candesartan cilexitil and Hydrochlorothaizide

Priyanka Bonu; Chaitanya B; H V Santhoshi  A; Divya M; Aruna  B

doi:10.37022/jiaps.v11i1.824

Bonu Priyanka Department of Pharmaceutical Analysis, Avanthi Institute of Pharmaceutical Sciences, Cherukupally, Vizianagaram, Andhra Pradesh, India.
B Chaitanya Department of Pharmaceutical Analysis, Avanthi Institute of Pharmaceutical Sciences, Cherukupally, Vizianagaram, Andhra Pradesh, India.
A H V Santhoshi Department of Pharmaceutical Analysis, Avanthi Institute of Pharmaceutical Sciences, Cherukupally, Vizianagaram, Andhra Pradesh, India.
M.Divya Department of Pharmaceutical Analysis, Avanthi Institute of Pharmaceutical Sciences, Cherukupally, Vizianagaram, Andhra Pradesh, India.
B.Aruna Department of Pharmaceutical Analysis, Avanthi Institute of Pharmaceutical Sciences, Cherukupally, Vizianagaram, Andhra Pradesh, India.

DOI https://doi.org/10.37022/jiaps.v11i1.824

Abstract

A simple, rapid, precise, and stability-indicating reverse phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of Candesartan cilexetil and Hydrochlorothiazide in pharmaceutical dosage forms. Chromatographic separation was achieved using a Symmetry C18 (150 × 4.6 mm, 3.5 µm) column with an isocratic mobile phase comprising Methanol: pH 3 phosphate buffer (70:30 % v/v) at a flow rate of 1 mL/min and detection at 240 nm. The method was validated according to ICH guidelines for system suitability, linearity, precision, accuracy, robustness, LOD, and LOQ. The calibration curves were linear over the concentration ranges of 16–80 ppm for Candesartan cilexetil and 25–150 ppm for Hydrochlorothiazide with satisfactory correlation coefficients. The %RSD values were below 2%, and recovery studies showed results within acceptable limits, confirming accuracy and precision. The developed method was found to be sensitive, reliable, cost-effective, and suitable for routine quality control analysis.

Keywords: RP-HPLC, Candesartan cilexetil, Hydrochlorothiazide, Method validation, Stability-indicating assay

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