Method development and validation for simultaneous estimation of amlodipine besylate and enalapril maleate in solid dosage form

Abstract

A rapid, sensitive, specific, accurate and precise high pressure liquid chromatographic method (HPLC) method involving UV detection has been developed for the determination and quantification of Amlodipine Besylate and Enalapril maleate in bulk and combined dosage form. The determination was carried out on a Phenomenex C18 column (Dimention : 250 x 4.6 mm, 5 μm). The sample was analysed using filtered and degassed mixture of methanol : 0.1N 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 7.6 min and for Enalapril maleate 3.2 min. Amlodipine besylate and Enalapril maleate showed a linear response in the concentration range of 10-50μg/ml. The correlation co-efficient ('r' value) for Amlodipine besylate and Enalapril maleate was 0.9992 and 0.9994, respectively. The method was validated in terms of linearity, precision, accuracy, specificity, robustness and solution stability. The proposed method can be used for routine analysis of Amlodipine Besylate and Enalapril maleate in bulk and combined dosage form