ISSN: 2249–9504
CAS CODEN: IJPCDX

DEVELOPMENT AND VALIDATION OF AN ACCURATE AND PRECISE LC-MS/MS METHOD FOR DETERMINATION OF TENOFOVIR AND EMTRICITABINE IN HUMAN PLASMA

Abstract

Author(s): Amit Patel, Ami Patel, Ashlesha Makwana

A simple, accurate and precise LC-MS/MS analytical method was developed and validated for the simultaneous assay of tenofovir and emtricitabine which are used for the treatment of HIV-infected patients. Extraction from human plasma was performed on Oasis MCX cartridges. The chromatographic separation was performed with Chromolith Speedrod RP18 column. The total chromatographic run time is 2.8 minutes. Both of the tenofovir and emtricitabine were monitored through positive ESI mode by MRM transitions 288.1>176.2 and 248.1>130.1 respectively. The validated linearity of this method was in the range of 3.030-1512.901ng/mL and 5.050- 2521.999ng/mL for tenofovir and emtricitabine respectively. Lower limit of quantitation (LLOQ) for both tenofovir and emtricitabine was achieved up to 3.030ng/mL and 5.050ng/mL respectively with a better signal to noise ratio. The correlation co-efficient (r) value for both the calibration curve was higher than 0.9992 for five precision and accuracy batches.

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