Абстрактный

A rapid stability indicating LC method for ramipril using RR-LC

I.V.Soma Raju, J.Sriramulu

A simple, sensitive isocratic RR-LC method has been developed for the quantitative determination of Ramipril Related compounds in Active Pharmacuetical Ingredient (API), used to treat hypertension and congestive heart failure. The developed method is also applicable for the Assay determination. Efficient chromatographic separation was achieved on a C18 stationary phase with simple mobile phase combination delivered in a isocratic mode and quantification was carried out using ultraviolet detection at 210 nmat a flowrate of 0.5mLmin-1. In the developed RRLCmethod the resolution between Ramipril and its four potential impurities was found to be greater than 3.0. Regression analysis shows an r value (correlation coefficient) of greater than 0.999 for Ramipril and itÂ’s all the four impurities. Thismethod was capable to detect all four impurities of Ramipril at a level of 0.05%with respect to test concentration of 1.0mgmL-1 for a 10 µL injection volume. The inter day precision values for all four impurities and for Ramipril was found to be within 5.0%RSD at its specification level. Themethod has shown good and consistent recoveries for Ramipril four impurities (99.0- 100.3%). TheActive Pharmacuetical Ingredient (API)was subjected to stress conditions of exposure to acid hydrolysis, Base hydrolysis Oxidation, Humidity, Photolysis and thermal degradation. Considerable degradation was found to occur in acid hydrolysis and Thermal stress conditions. The developed RR-LC method was validated with respect to linearity, accuracy, precision.