Abstract

ANALYTICAL METHOD VALIDATION FOR CONTENT OF EMTRICITABINE AND TENOFOVIR IN EMTRICITABINE AND TENOFOVIR TABLET FORMULATION BY RP-HPLC

Sekar V., Devi V.*, Sambath Kumar R.

ABSTRACT

A Simple, Accurate, Precise and rapid Analytical Method Validation for Content of Emtricitabine and Tenofovir in Emtricitabine and Tenofovir Tablet Formulation by RP-HPLC method. The chromatographic separation was performed on as Phenomenex Luna C18 (150cm 4.6mm 5μ)column, using a mobile phase consisting of a mixture of Acetonitrile and Potassium dihydrogen ortho phosphate was selected and pH 3.4 was adjusted with OPA in the ratio of 40:60(v/v) at a flow rate of 1ml/min. The detection of wavelength was 260nm.The method was found to be linear in the range of 50ug/ml to 300ug/ml and 75ug/ml to 450ug/ml for Emtricitabine and Tenofovir standard drugs respectively. The % RSD was found to be within the limit as per ICH guidelines. The method was validated with respect to linearity, accuracy, system suitability and precision, limit of detection and limit of quantitation. The above method developed was reproducible with good resolution and the results of analysis have been validated with correlation coefficient of 0.999. The drugs were found to be within the limit.

Keywords: Emtricitabine, Tenofovir, RP-HPLC, ICH, Validation.