Abstract
An accurate, precise, and reproducible HPLC-MS-based stability-indicating was developed and validated for the simultaneous quantitative determination of Azelnidipine (AZL) and Chlorthalidone (CTE). HPLC-MS method employs an X Bridge C18 column (5 μm, 4.6 x 250 mm) and a mobile phase, 5mM Potassium dihydrogen phosphate: Acetonitrile (10:90 v/v) ratio with, pH 7.8 adjusted using Triethylamine, for the simultaneous determination of AZL and CTE. The detection was carried out at 261 nm with a flow rate of 1.0 ml/min. The method reveals linearity over the concentration ranges of 0.1-0.6 mcg/ml for AZL and 0.16-0.96 mcg/ml for CTE with correlation coefficients of 0.9901 and 0.9988, respectively. Precision (%RSD) for intraday analysis was found to be 0.98% for AZL and 0.88% for CTE. Accuracy was negotiated at three different concentrations, and the results indicated %Recovery within acceptable limits. Limits of detection and quantification were determined to be 52 ng/ml and 45.6 ng/ml for both compounds, respectively.. KEYWORDS :Azelnidipine, Chlorthalidone, LC-MS, Stability-Indicating method, Method development.
Published Version
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