A liquid chromatography tandem mass spectrometry based regulatory compliant method for the determination of tenofovir in human serum

A liquid chromatography tandem mass spectrometry based regulatory compliant method for the determination of tenofovir in human serum

A simple, rapid, and specific assay based on solid phase extraction and liquid chromatography-electrospray ionization tandem mass spectrometry (LC-ESI MS-MS) for the quantitative analysis of Tenofovir in human serum using Tenofovir D6 as internal standard (IS) have been developed. The precursor to p...

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Bibliographic Details
Published in:Drug research Vol. 64; no. 6; p. 306
Main Authors: Paliwal, N, Jain, P, Dubey, N, Sharma, S, Khurana, S, Kumar Paliwal, S
Format: Journal Article
Language:English
Published: Germany 01-06-2014
Subjects:
Adenine - analogs & derivatives
Adenine - blood
Chromatography, Liquid - methods
Cold Temperature
Drug Stability
Humans
Organophosphonates - blood
Reproducibility of Results
Tandem Mass Spectrometry - methods
Tenofovir
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Description
Summary:A simple, rapid, and specific assay based on solid phase extraction and liquid chromatography-electrospray ionization tandem mass spectrometry (LC-ESI MS-MS) for the quantitative analysis of Tenofovir in human serum using Tenofovir D6 as internal standard (IS) have been developed. The precursor to product ion transitions of m/z 288.2/176.2 and m/z 293.9/182.3 used to measure the analyte and internal standard (Tenofovir and Tenofovir D6). The method was validated over a concentration range of 5.06-603.72 ng mL(-1). The method was validated over the parameters like selectivity, matrix effect, sensitivity, linearity, precision, accuracy, various stabilities (bench top stability, standard stock solution stability in refrigerator and at room temperature, stock dilution stability, auto sampler stability, freeze thaw stability, long term stability - 65°C±10°C & long term stability - 22°C±5°C, reagent stability, dry extract stability, wet extract stability in refrigerator and at bench top, blood stability), effect of potentially interfering drugs, dilution integrity, recovery and reinjection reproducibility. The mean % recovery of Tenofovir was 98.22% with a precision of 2.42%, The mean % recovery of Tenofovir D6 was 100.96% with a precision of 2.88%. The RSD % of intra-day and inter-day assay was≤15%.
ISSN:2194-9387
DOI:10.1055/s-0033-1361090