Abstract

METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC FOR SIMULTANEOUS ESTIMATION OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

B.Mohan Gandhi, A. Lakshmana Rao* and J. Venkateswara Rao

ABSTRACT

A simple, precise, reliable, rapid and reproducible reversed-phase high performance liquid chromatographic method was developed and validated for the simultaneous estimation of Emtricitabine and Tenofovir disoproxil fumarate. Chromatography is carried out isocratically on C8 Phenomenex Luna (4.6X250 mm) column with a mobile phase composed of acetonitrile: phosphate buffer (60:40 v/v) at a flow rate of 1 ml/min. Detection was carried out using a UV detector at 260 nm. Parameters such as linearity, precision, accuracy, specificity and ruggedness are studied as per the ICH Q2(R1) guidelines. The retention times of Emtricitabine and Tenofovir are 2.883 min and 3.890 min respectively. The linearity range and % recoveries of Emtricitabine and Tenofovir are 40-240 μg/ml, 60-360 μg/ml and 99.84%, 99.75% respectively. The correlation coefficients of Emtricitabine and Tenofovir are 0.999. The % relative standard deviations for three replicate measurements in three concentrations of samples in tablets are always less than 2%. Developed method was found to be accurate, precise, selective and rapid for simultaneous estimation of Emtricitabine and Tenofovir in pharmaceutical dosage forms. The proposed method can be useful in quality control of bulk manufacturing and pharmaceutical dosage forms.

Keywords: Emtricitabine and Tenofovir disoproxil fumarate, HPLC, Validation, Retention time.