Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF EMTRICITABINE IN SYNTHETIC MIXTURE

K.Sujatha, *T.Sheela Rani K.Anand Babu, K.Kavitha, K.Chitra

Abstract

A facile, sensitive, accurate and validated HPLC method has been developed to determine Emtricitabine in bulk drug and synthetic mixture. Chromatographic separation is conducted on Phenomenox C18 (250mm x 4.6mm,5μm) column at ambient temperature using sodium dihydrogen orthophosphate (0.02M) and methanol (50:50v/v) as a mobile phase and at a flow rate 1ml/minute at a wavelength of 280 nm. The retention time for Emtricitabine was found to be 3.5minute. The Calibration graph was plotted over the range of 80- 240μg/ml with correlation coefficient 0.9990. The limit of detection (LOD) and limit of quantification (LOQ) for Emtricitabine were 0.0112 and 0.0375μg/ml. Accuracy was between 99.53% and 100.01%. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The newly developed method was validated according to the ICH guidelines with respect to linearity, accuracy, precision and specificity.

Keywords: Emtricitabine, Validation, Synthetic mixture, ICH Guidelines.