Validated HILIC–MS/MS assay for determination of vindesine in human plasma: Application to a population pharmacokinetic study

Mean plasma concentration–time profiles of intravenous injection of 3mg Vindesine Sulfate for Injection to 100 unrelated Chinese Han subjects with hematological malignant disorders. •HILIC separation mode coupled to ESI-MS/MS was used for quantitative analysis.•The analytes of interest were well sep...

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Published inJournal of pharmaceutical and biomedical analysis Vol. 96; pp. 31 - 36
Main Authors Zhu, Rong-Hua, Li, Huan-De, Cai, Hua-Lin, Jiang, Zhi-Ping, Xu, Ping, Dai, Li-Bo, Peng, Wen-Xing
Format Journal Article
LanguageEnglish
Published England Elsevier B.V 05.08.2014
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Summary:Mean plasma concentration–time profiles of intravenous injection of 3mg Vindesine Sulfate for Injection to 100 unrelated Chinese Han subjects with hematological malignant disorders. •HILIC separation mode coupled to ESI-MS/MS was used for quantitative analysis.•The analytes of interest were well separated with sharp and symmetrical peak shapes.•The method is simple, sensitive, good specificity, robust and time efficient.•Successfully applied to a population pharmacokinetic study in Chinese Han subjects with hematological malignant disorders. The first HILIC–tandem mass spectrometry (MS/MS) method for determination of vindesine (VDS) in human plasma using vinorelbine as an internal standard (IS) has been developed and validated. Plasma samples clean-up consisted of solid phase extraction with a strata™-X column. The compounds were separated on a HILIC column with an isocratic mobile phase consisting of acetonitrile and 15mM ammonium acetate buffer containing 0.15% formic acid (80:20, v/v). The detection was performed on a triple quadrupole tandem mass spectrometer via electrospray positive ionization (ESI+). The ion transitions recorded in multiple reaction monitoring mode were m/z 754.6→123.8 for VDS and 779.4→323.3 for IS, respectively. Linear calibration curves were obtained in the concentration range of 0.3–28ng/ml and the lower limit of quantification for VDS was 0.3ng/ml. The coefficient of variation of the assay precision was less than 13%, and the accuracy exceeded 96%. The developed assay method was successfully applied for the evaluation of population pharmacokinetics of VDS after intravenous infusion of Xi Ai Ke Vial® (3mg of Vindesine Sulfate for Injection) to Chinese Han subjects with hematological malignant disorders.
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content type line 23
ISSN:0731-7085
1873-264X
DOI:10.1016/j.jpba.2014.03.017