Friday , 19 July 2024

Development and validation of a LC-MS/MS assay for bioequivalence study of dolutegravir, emtricitabine, Tenofovir alafenamide in human plasma

Kiran Kumar.A1*, Komal Lata Nagpal2 and Jaswanth Kumar.I3
1Research scholar, Department of Life sciences, OPJS University, Churu, Rajasthan -313301, India.
2Associate Professor, Department of Life sciences, OPJS University, Churu, Rajasthan -313301, India.
3Jaswanth Kumar.I, Head-Operations, Clinse labs private limited, Balanagar, Hyderabad, TG- 500037, India.

Combination antiretroviral (cARV) treatment is more common in human immunodeficiency virus (HIV) infection. In many instances, treatment regimen includes two or more combination of drugs from six different classes. Some of the antiretroviral combination medications are under study at preclinical and clinical stages. A precise method is required to quantify the drug concentration in biological matrices to study pharmacokinetic behavior and tissue distribution profile in animals and/or humans. We have developed and validated a sensitive and precise liquid chromatography–tandem mass spectrometry method for simultaneous quantification of selected antiretroviral drugs, Dolutegravir, Emtricitabine, Tenofovir Alafenamide in human plasma samples. This method involves a solid phase extraction, simple isocratic mobile phase Methanol: 5Mm ammonium acetate (75:25), chromatographic separation using ZODIAC CN, 5µ, 100 X 4.6mm column and mass spectrometric detection by an API 4500 instrument. The total run time for each sample was 3 min.. The results of intra and inter-run assay precision and accuracy were within acceptance limits for all the three analytes. This study was designed to evaluate the bioequivalence of fixed dose combination of Dolutegravir, Emtricitabine and Tenofovir Alafenamide Tablets 50mg/200mg/25mg (Test formulation) with Dolutegravir, Emtricitabine and Tenofovir Alafenamide Tablets 50mg/ 200mg/ 25mg (Reference formulation) in 12 healthy male volunteers under fed conditions.
Keywords: Dolutegravir, Emtricitabine, Tenofovir Alafenamide, LC-MS/MS, Bioequivalence; Human Plasma, Pharmaco kinetic parameters.

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