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Method Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Atenolol and Lercanidipine in Bulk and its Pharmaceutical Formulations

Brahma Reddy Gade, Sita Ram Bandhakavi and Ganji Ramanaiah

A new rapid, precise and sensitive reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the estimation of Atenolol and Lercanidipine simultaneously in combined dosage form. The two components Atenolol and Lercanidipine were well resolved on an isocratic method, C18 column, utilizing a mobile phase composition of acetonitrile: methanol: a buffer of 0.02M Potassium dihydrogen phosphate buffer (50:10:40), v/v, pH 5.0) at a flow rate of 1.0 mL/min with UV detection at 226 nm. The retention time of Atenolol and Lercanidipine were 2.0 min and 3.5 min respectively. The developed method was validated for specificity, linearity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ) and robustness as per ICH guidelines. Linearity for Atenolol and Lercanidipine were found in the range of 208-624 µg/ml and 40-120 µg/ml, respectively. The percentage recoveries for Atenolol and Lercanidipine ranged from 98-101 % and 97-101 %, respectively. The proposed method could be used for routine analysis of Atenolol and Lercanidipine in their combined dosage forms.

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