DEVELOPMENT AND VALIDATION OF A RP- HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ENALAPRIL MALEATE AND RAMIPRIL IN BULK AND TABLET DOSAGE FORM
Journal Title: Int J of Pharm Res & Analy - Year 2013, Vol 3, Issue 1
Abstract
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 an 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: 2gm of sodium perchloride 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 sodium perchloride 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.
Authors and Affiliations
Govardhan Bathula , N. Sriram, M. Jawahar
Keywords
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- EP ID EP157967
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