Abstract

A STABILITY-INDICATING UPLC METHOD FOR SIMULTANEOUS QUANTIFICATION OF EMTRICITABINE, EFAVIRENZ AND TENOFOVIR DISOPROXIL FUMARATE IN BULK AND PHARMACEUTICAL DOSAGE FORMS

Kiran Kumar Ankalla* and Nageswara Rao G.

ABSTRACT

A specific, precise, rapid and reliable stability indicating UPLC method has been developed and validated for simultaneous separation and estimation of Emtricitabine, Efavirenz and Tenofovir Disoproxil Fumarate in bulk drug mix and pharmaceutical dosage forms. Chromatographic separation was achieved on an Acquity UPLC BEH Phenyl (2.1 x 100 mm, 1.7 μm) column using gradient composition of 0.1% Orthophosphoric acid (OPA) as Mobile Phase A and Acetonitrile as Mobile Phase B at a flow rate of 0.5 mL/min and analytes were monitored at 265nm. The retention times of the Emtricitabine, Efavirenz and Tenofovir disoproxil fumarate were about 0.68, 2.10 and 1.34 mins respectively. The results of specificity studies indicate that there was no interference of diluent, excipients, impurities and degradation products at respective retention times of analytes and it is assured that the peak response was belongs to a single component only. The detector response was linear in the range of 10-150% level with respect to test concentration of Emtricitabine, Efavirenz and Tenofovir Disproxil Fumarate. Correlation coefficient (R2) was not less than 0.999 for all three analytes. The percentage assay of Emtricitabine, Efavirenz and Tenofovir disoproxil fumarate were about 99.612, 99.866 and 99.822% respectively. The developed method was validated for specificity, linearity, precision, accuracy, solution stability, ruggedness and stress degradation studies were monitored. Hence, the developed method was specific, rapid and cost-effective and it can be used for routine analysis of these drugs in bulk and pharmaceutical dosage forms.

Keywords: Emtricitabine; Efavirenz; Tenofovir disoproxil fumarate; UPLC.