Original Articles: 2018 Vol: 10 Issue: 9
Stability Indicating Method Development and Validation for the Simultaneous Estimation of Amlodipine and Chlorthalidone in Bulk and Pharmaceutical Dosage form by RP-HPLC
Abstract
A simple, rapid and accurate RP-HPLC method was developed to determine the drug such as Amlodipine and chlorthalidone in bulk and pharmaceutical dosage form .The chromatographic separation performed on a shim pack GWS C18(250 mm length x 4.6 mm ,5μ). The eluent were monitored on UV Visible detector at a wavelength of 266nm using mixture of 0.1% formic acid: methanol: acetonitrile in the ratio of (50:5:45v/v) at pH 3 the flow rate 1ml/min. Validation parameters such as system suitability, linearity, precision, accuracy, specificity, limit of detection (LOD) and limit of quantification (LOQ), stability of sample and standard stock solutions and robustness were studies to reported in the ICH guidelines. The retention time of Amlodipine and chlorthalidone was 4.8min, 3.9 min respectively. Assay method further evaluated for Amlodipine and chlorthalidone analysis at low concentration of analyte and found limit of detection 0.78,0.60 μg/mL and limit of quantification is 2.2,1.83 μg/mL respectively. Linearity of Amlodipine and chlorthalidone was from 5-25 μg/mL and 12.5-62.5 μg/mL and the R2 is 0.998. The method was fast, accurate, precise and sensitive hence it can be employed for routine quality control analysis of Amlodipine and chlorthalidone in pure and tablet dosage form.