Author(s): NAJMA SULTANA, NAJMA SULTANA, NAJMA SULTANA
Simple, specific, economical and precise high performance liquid chromatographic method for the simultaneous determination of enalapril in presence of statins (rosuvastatin, atorvastatin and simvastatin) in API (active pharmaceutical ingredient) and formulation has been developed and validated. Chromatography was carried out at 25"C on a prepacked Purospher Star, C18 (5 mm, 250 x 4.6 mm) column with the isocratic mobile phase of acetonitrile: water (60:40 v/v) adjusting pH to 2.8. The UV detection was carried at 230 nm. The results obtained showed good agreement with the declared contents. Enalapril and statins separated in less than 10 mins with good resolution and minimal tailing and without interference of excepients. The method was linear in the range of 2.5-100 μgmL-1 for enalapril concentration with a correlation co-efficient 0.9995 and in the range 0.625-25 μgmL-1 for statins concentrations having correlation coefficient 0.9990 (inter and intraday CV<2 .0%). The recovery was 99-102%. The method was validated according to ICH guidelines and the acceptance criteria for accuracy, precision, linearity, specificity and system suitability were met in all cases. The proposed method can be used for quantitative determination of enalapril and statins alone or in combination from API and formulations.