This work is concerned with application of simple, accurate, precise and highly selective UV First derivative spectrophotometric and reverses phase high performance liquid chromatographic (RP-HPLC) method for simultaneous estimation of Simvastatin and Gefitinib in synthetic mixture. The first method was based on UV-First derivative spectrophotometric determination of two drugs which involves absorbance measurement at 237.2 nm (Simvastatin) and 348.0 nm (Gefitinib) in methanol. Linearity was obtained in the range of 1-3.5 μg/ml and 6-21 μg/ml for Simvastatin and Gefitinib respectively. Chromatographic separation was achieved isocratically at 25°C±0.5°C on Enable C18 column (250 х 4.6 mm i.d.) with a mobile phase composed of acetonitrile: methanol: water in the ratio of 60: 30: 10 % v/v/v at flow rate of 1.0 ml/min. The retention time of Simvastatin and Gefitinib was found to be 7.73 min and 5.23 min. respectively. The method was found to be linear in the range of 0.1-15 μg/ml for Simvastatin and 0.6-90 μg/ml for Gefitinib with mean recovery of 101.43±0.48% for Simvastatin and 100.63±0.45% for Gefitinib. The correlation coefficients for all components are close to 1. The developed methods were validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Thus the proposed method was successfully applied for simultaneous determination of Simvastatin and Gefitinib in routine analysis.
Loading....