Development and Validation of RP-HPLC Method for Simultaneous Estimation of Enalapril Maleate and Amlodipine Besylate in Combined Dosage form.
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Date
2012-09
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Abstract
A simple, precise and rapid reverse-phase HPLC method has been developed and subsequently validated for
the simultaneous estimation of Amlodipine besylate and Enalapril maleate from their combination drug
product. The proposed RP-HPLC method utilizes a Phenomenex C18, 5 μm, 250 mm × 4.6 mm i.d. column,
at ambient temperature, optimum mobile phase consisted of Methanol: Acetonitrile : Water (40:50:10,
v/v/v), effluent flow rate monitored at 1.0 mL min-1, and detection using PDA detector. The described
method was linear over the range of 0.5-6.0 g/ml and 0.5-8.0 g/ml for Enalapril maleate and Amlodipine
besylate, respectively. The mean recovery was found to be 100.06 ± 0.49 % and 99.98 ± 0.63 % for Enalapril
maleate and Amlodipine besylate, respectively. The intermediate precision data obtained under different
experimental setup, the calculated value of coefficient of variation (CV, %) was found to be less than critical
value. The proposed method can be useful in the quality control of bulk manufacturing and pharmaceutical
dosage forms.
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Keywords
Enalapril maleate, Amlodipine besylate, RP-HPLC, Validation
Citation
Chaudhari Bharat G. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Enalapril Maleate and Amlodipine Besylate in Combined Dosage form. Journal of Applied Pharmaceutical Science. 2012 Sept; 2(9): 54-57.