Mon, 20 Nov 2017

A New RP-HPLC method for the Simultaneous Estimation of Emtricitabine, Efavirenz and Tenofovir in Tablet Dosage forms

C. Palavan*1, LA Ramaprasad2, P Srinivasu2, JVLN Seshagiri Rao3

1.Andhra University College of Pharmaceutical Sciences, Visakhapatnam-530 003, India.

2.Analytical Development Division, Hetero Drugs Ltd., Unit-3, Jeedimetla, Hyderabad-500 055, India.

3.Yalamarty Pharmacy College, Tarluwada, Visakhapatnam-530 052, India.


ABSTRACT

An accurate, precise and reproducible high performance liquid chromatographic method was developed for quantitative estimation of emtricitabine, efavirenz and tenofovir disoproxil fumarate simultaneously in tablet dosage forms. Separation of the drugs was achieved within 15.0 min on a Xterra RP-18 column (150 x 4.6 mm; 5µ) by gradient elution using mixtures of ammonium acetate buffer and acetonitrile as the mobile phase. The analytes in the eluate were monitored at 260 nm. The retention times obtained for emtricitabine, efavirenz and tenofovir disoproxil fumarate were 4.611, 9.098 and 7.512 min respectively. The calibration curves were linear over the range of 20.11-60.33 µg/mL for emtricitabine, 60.28-180.45 µg/mL for efavirenz and 30.13-90.18 µg/mL for tenofovir disoproxil fumarate. The performance of the method was validated according to ICH guidelines. The method was found to be suitable for accurate determination of these drugs in tablet dosage forms without any interference from excipients or endogenous substances.

Keywords: Emtricitabine, Efavirenz, Tenofovir disoproxil fumarate, Determination, HPLC, Gradient elution.


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