A Liquid Chromatography Tandem Mass Spectrometry Based Regulatory Compliant Method for the Determination of Tenofovir in Human Serum

Abstract

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%.

Novel approaches for determination of antiretroviral reverse transcriptase inhibitor agent in commercial dosage forms by using spectrofluorimetric, first derivative spectrophotometric, and HPLC methods

“…Our study is simple to be used in routine laboratories and its analysis time is short [8]. Our study is suitable for green chemistry compared to the studies in the literature [15,30,32].…”

“…In the literature, tenofovir has been determined as the only active ingredient and in combination with other active ingredients. These methods include HPLC [3][4][5][6][7][8], HPLC-MS [9], HPLC-MS/MS [10,11], LC-MS [12][13][14], LC-MS/MS [15][16][17][18], UPLC [19][20][21][22][23][24][25], UPLC-MS and UPLC-MS/MS [22][23][24][25], TLC [26], HPTLC [27][28][29], and spectrophotometric [7,[30][31][32][33][34] methods. This paper describes new, simple, sensitive, and rapid spectrofluorimetric method for the determination of tenofovir in pharmaceutical dosage form.…”

Liquid Chromatographic Determination of Solifenacin Succinate, Flavoxate Hydrochloride and Tolterodine Tartrate in Bulk Drugs and Their Pharmaceutical Dosage Forms

“…Literature survey revealed that few chromatographic methods for SOLS [6][7][8][9][10][11][12][13][14][15][16][17], FLXHC [18][19][20][21] and TOLT [22][23][24][25][26][27][28][29], spectrophotometric methods for SOLS [30,31], FLXHC [32,33] and TOLT [34][35][36], potentiometric method Equivalent weights of 10 mg of SOLS, 20 mg of FLXHC and 20 mg of TOLT were transferred into three 100 mL clean dry volumetric flasks containing 70 mL of mobile phase and the mixture was sonicated to dissolve the powder. The volume was made up to the mark with the same solvent.…”

Development and Validation of an Lc-MS/MS Method for the Determination of Tenofovir and Emtricitabine

“…Tenofovir and emtricitabine inhibit Human Immuno-deficiency Virus (HIV) reverse transcriptase and lower the amount of HIV in the body. They are administered together as part of highly active antiretroviral therapy (HAART) [5,6]. A bioanalytical method is needed to determine drug concentrations in biological fluids like plasma for purposes of therapeutic drug monitoring and pharmacokinetic studies.…”