Stability Indicating RP-UPLC Method for the Quantitative Determination of Degradation Impurities of Benidipine Hydrochloride & Metoprolol Succinate in Combined Dosage Form
摘要
A suitable RP-UPLC method for the quantitative analysis of degradation impurities of Benidipine hydrochloride & Metoprolol succinate is reported. The method was validated for specificity, linearity, range, accuracy, precision, sensitivity (LOQ and LOD), and robustness. The method shows excellent linearity with linear regression (r > 0.9950) within concentration range (0.5 to 3.0 µg/mL). LOD values were 0.14, 0.16 and, 0.15 and LOQ values were 0.42, 0.49 and 0.45 µg/mL for MET impurity-B & O and BEN impurity-2, respectively. The proposed method could be applied to routine quality control analysis.