Determination of paclitaxel in human plasma by LC-ESI-MS and its application in a pharmacokinetic study

doi:10.5246/jcps.2012.04.041

Abstract

Abstract:

A sensitive and selective method has been developed and validated for the quantitation of paclitaxel in human plasma by liquid chromatography-electrospray ionization mass spectrometry (LC-ESI-MS). Paclitaxel and norethindrone (used as internal standard, I.S.) were extracted from human plasma by a one-step liquid-liquid extraction with t-butyl methyl ether. Separation on a Zorbax SB-C18 column (100 mm×2.1 mm, 3.5 μm, Agilent) was achieved by gradient elution with methanol and 0.2 mmol/L ammonium formate containing 0.1% formic acid. The selected-ion monitoring (SIM) targeted ions of [M+Na]⁺ at m/z 876.5 for paclitaxel and [M+H]⁺ at m/z 299.4 for I.S. The assay was validated in the range of 1.0-400 ng/mL (r>0.998) with LLOQ of 1.0 ng/mL. Intra- and inter-day precisions were all less than 9.0%, with accuracies of ±6.8%. The method was successfully applied to evaluate the pharmacokinetics of paclitaxel liposome for injection in patients.

Key words: Paclitaxel, LC-MS, Pharmacokinetics

CLC Number:

R917

Supporting:

Jun Qian, Yi-Xuan Wang, Sheng-Min Su, Yun-Qiu Yu^*. Determination of paclitaxel in human plasma by LC-ESI-MS and its application in a pharmacokinetic study [J]. , DOI: 10.5246/jcps.2012.04.041.

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Determination of paclitaxel in human plasma by LC-ESI-MS and its application in a pharmacokinetic study

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