Stability Indicating Validated RP-HPLC Method for Simultaneous Determination of Perindopril Erbumine and Amlodipine Besylate in Bulk and Pharmaceutical Dosage Form

摘要

The aim of this work was focused on to develop and validate an accurate, simple, precise, rapid, and stability-indicating reversed phase high performance liquid chromatography (RP-HPLC) method for simultaneous estimation of Perindopril Erbumine (PDE) and Amlodipine Besylate (AMD) in bulk drugs and their combined commercial tablets. The chromatographic separation was performed on a YMC C18 (250mm×4.6mm I.D; 5 μm) column, with a mobile phase comprising of a mixer of Orthophosphoric acid (0.1%) pH 2.1 and Methanol (40:60 ), at a flow rate of 1 ml/min, with detection at 262nm.Retention times of Perindopril Erbumine and Amlodipine Besylate were found to be 2.2 min and 3.1min respectively. The developed method was validated according to ICH guidelines. Linearity of Perindopril Erbumine was found to be in the range of 4-12μg/ml and that for Amlodipine Besylate was found to be in the range of 5-15μg/ml. The percentage recoveries for both drugs were found in the range of 97-102%. The limits of detection values were found to be 2.96μg/ml and 2.72μg/ml for Perindopril Erbumine and Amlodipine Besylate respectively. The proposed RP-HPLC method is simple, rapid, isocratic, specific, accurate and precise. Hence, this method can be recommended for the estimation of Perindopril Erbumine (PDE) and Amlodipine Besylate (AMD) in pharmaceutical dosage form.