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Development and validation of a RP- HPLC method for simultaneous estimation of enalapril maleate and ramipril in bulk and tablet dosage form | Abstract
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Abstract

Development and validation of a RP- HPLC method for simultaneous estimation of enalapril maleate and ramipril in bulk and tablet dosage form

Author(s): G. Nagarajan, B. Govardhan1, B. V. Ramana, K. Sujatha, S. Rubina, T. Arundathi and R. Soumya

A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous determination of Enalapril maleate and Ramipril in bulk and tablet dosage form. Chromatographic analysis was performed on a Oyster BDS C18 column (250x 4.6 mm, 5μm) column temperature 65°C with a mixture of buffer A and buffer B in the ratio 50:50 [Buffer A preparation: 2 gm of sodiumperchloride in 800ml water and add 0.5 ml tri ethyl amine, adjust the pH to 3.6±0.1 with phosphoric acid and add 200 ml of acetonitrile. Buffer B preparation: 2 gm of sodiumperchloride in 300 ml water and add 0.5 ml tri ethyl amine, adjust the pH to 2.6±0.1 with phosphoric acid and add 700 ml of acetonitrile] as mobile phase, at a flow rate of 1.0 mL min-1. UV detection was performed at 208 nm. The method was validated for accuracy, precision, specificity, linearity and sensitivity. The retention times of Enalapril maleate and Ramipril were 4.197 and 5.819 min, respectively. Calibration plots were linear over the concentration ranges 5–30 μg mL-1 and 5–30 μg mL-1 for Enalapril maleate and Ramipril, respectively. The Limit of detection was 0.571 and 1.090 μg mL-1 and the quantification limit was 1.733 μg mL-1 and 3.303 μg mL-1 for Enalapril maleate and Ramipril, respectively. The accuracy of the proposed method was determined by recovery studies and found to be 98.06% to 100.47%. Commercial tablet formulation was successfully analyzed using the developed method and the proposed method is applicable to routine analysis of determination of Enalapril maleate and Ramipril in bulk and tablet dosage form.