米国先進ドラッグデリバリージャーナル オープンアクセス

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Method Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Perindopril Erbumine and Amlodipine Besylate in Bulk and its Pharmaceutical Formulations

Kalpana Nekkala, V. Shanmukha Kumar J, D. Ramachandran, Ganji Ramanaiah and Ganta Srinivas

A new rapid, precise and sensitive reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the estimation of Perindopril and Amlodipine simultaneously in combined dosage form. The two components Perindopril and Amlodipine were well resolved on an isocratic method, C18 column, utilizing a mobile phase composition of acetonitrile: methanol: a mixed buffer of 0.02M Potassium dihydrogen phosphate buffer and 0.02M Sodium dihydrogen Phosphate buffer with 1mL Tri ethyl amine (40:20:40), v/v, pH 5.0) at a flow rate of 1.0 mL/min with UV detection at 226 nm. The retention time of Perindopril and Amlodipine were 2.9 min and 4.9 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 Perindopril and Amlodipine were found in the range of 48-112 μg/ml and 60.0-140.0 μg/ml, respectively. The percentage recoveries for Perindopril and Amlodipine ranged from 98.9-100.4 % and 98.9-100.7 %, respectively. The proposed method could be used for routine analysis of Perindopril and Amlodipine in their combined dosage forms.

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