A rapid and sensitive LC/ESI–MS/MS method for quantitative analysis of docetaxel in human plasma and its application to a pharmacokinetic study

Abstract

Docetaxel is a taxane family antineoplastic agent widely employed in cancer chemotherapy. We developed a liquid chromatography/tandem mass spectrometry method for the determination of docetaxel in human plasma. Plasma samples were deproteinized by acetonitrile containing internal standard paclitaxel. Chromatographic separation was performed on a TSKgel ODS-100 V 3 μm (50 mm × 2.0 mm i.d.) column using a mobile phase composed of acetonitrile-methanol-water-formic acid (50:5:45:0.1, v/v/v/v). Detection was performed on a triple-quadrupole tandem mass spectrometer with multiple reaction monitoring (MRM) mode via electrospray ionization (ESI) source. This method covered a linearity range of 5-5000 ng/mL with the lower limit of quantification of 5 ng/mL. The intra-day precision and inter-day precision (R.S.D.) of analysis were less than 6.7%, and the accuracy (R.E.) was within ± 9.0% at the concentrations of 5, 20, 200, and 2000 ng/mL. The total run time was 5.0 min. This method was successfully applied for clinical pharmacokinetic investigation.

Antineoplastic drugs and their analysis: a state of the art review

“…11 and Table 6, respectively. Most methods for taxanes analysis are based on RPLC coupled to MS 305,309,[426][427][428][429][430][431][432][433][434][435][436][437][438][439][440][441][442] and UV detection. 138,269,[443][444][445][446][447][448][449][450][451][452][453] LODs lower than 0.05 ng mL −1 were reached for the analysis of docetaxel in blood using a column-switching method involving a preconcentration step on a trapping column, prior to LC-MS analysis.…”

Mass spectrometry in the pharmacokinetic studies of anticancer natural products

“…Three different extraction procedures, PP, LLE and SPE are described to clean up the biological samples. PP is the fastest extraction method and it was employed by 6 authors: some of them (Yamaguchi et al, ; Marzinke et al, ) used PP alone as sample preparation while some other associated PP to SPE (Sottani et al, ; Gardner et al, ; Corona et al, ; Navarrete et al, ). Navarrete et al, for PP, used a solution of zinc sulphate in methanol (30:70 v/v) in order to obtain the lysis of erythrocytes and consequently a very clean supernatant (Navarrete et al, ).…”

“…Navarrete et al, for PP, used a solution of zinc sulphate in methanol (30:70 v/v) in order to obtain the lysis of erythrocytes and consequently a very clean supernatant (Navarrete et al, ). Gardner et al and Yamaguchi et al used only acetonitrile, the former to quantify paclitaxel following Abraxane treatment and the latter to determine docetaxel (Gardner et al, ; Yamaguchi et al, ). The extraction volume was one to threefold the volume of the biological sample to treat.…”

Quantification of Taxanes in Biological Matrices: A Review of Bioanalytical Assays and Recommendations for Development of New Assays

“…Bioanalytical assays for quantification of paclitaxel [56][57][58][59][60][61][62][63][64][65][66][67][68][69][70] (SupplemenTary Table 2), paclitaxel and its metabolites [71][72][73][74][75] (SupplemenTary Table 3), or paclitaxel and other drugs (including docetaxel) [76][77][78][79][80][81][82] (S upplemenTary Table 5) by LC-MS/MS are widely described. For quantification of docetaxel [83][84][85][86][87][88][89][90], docetaxel and its metabolites [91,92] (SupplemenTary Table 4), or docetaxel and other drugs [93][94][95] (Supplemen- Tary Table 5), fewer assays are published. A limited number of LC-MS/MS assays are developed for the quantification of the second-generation taxanes cabazitaxel [96,97], fe...…”

“…Hou et al used methanol and acetonitrile (1:1, v/v) as the precipitation solvent [85], while Yamaguchi et al used only acetonitrile. Extraction recoveries of docetaxel were above 77% [88]. Often the volume of the extraction solvent is two-to four-times the volume of the sample, although Kumar et al used an eightfold higher volume of solvent [23].…”