Development and validation of HPLC method for simultaneous estimation of Amlodipine besylate and Enalapril maleate in solid dosage form

Abstract

A rapid, sensitive and specific HPLC method involving UV detection was developed and validated for determination and quantification of Amlodipine besylate and Enalapril maleate in tablet dosage form. The determination was carried out on a Phenomenex C18 (250 x 4.6 mm, 5 μm) column using filtered and degassed mixture of methanol: 1N HCl (1:1) as mobile phase at a flow rate of 1ml/min and effluent was monitored at 218nm. The retention time for Amlodipine besylate was 8.062 min and for Enalapril maleate 2.457 min. Amlodipine besylate and Enalapril maleate showed a linear response in the concentration range of 10-60μg/ml. The correlation co-efficient ('r' value) for Amlodipine besylate and Enalapril maleate was 0.9938 and 0.999, respectively. The method was validated in terms of linearity, precision, accuracy, specificity, robustness and solution stability. The proposed method can be useful in the quality control of bulk manufacturing and pharmaceutical dosage forms.