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Development and validation of an ultrafiltration-UPLC-MS/MS method for rapid quantification of unbound docetaxel in human plasma.
J Chromatogr B Analyt Technol Biomed Life Sci. 2014 Sep 15; 967:28-35.JC

Abstract

Docetaxel lipid microsphere (DT-LM) is a novel formulation of docetaxel without Tween-80. A sensitive, robust and reproducible ultrafiltration (UF) followed by UPLC-MS/MS method was developed and validated for the quantification of unbound docetaxel in human plasma using paclitaxel as IS. Ultrafiltrate samples were chromatographed on Acquity UPLC BEH C18 column (50 mm × 2.1 mm, 1.7 μm). The mobile phase was a mixture of 10mM ammonium formate in water containing 0.2% formic acid (A) and acetonitrile containing 0.2% formic acid (B). The volume of plasma utilized was only 450 μL. The calibration curve was linear over the range of 0.2-200 ng/mL, with LLOQ of 0.2 ng/mL. The method was shown to be reliable and reproducible with intra- and inter-day precision and accuracy <±15%, and extraction recovery of 98.1-104.8%. Docetaxel was stable during stability studies, e.g., short term, post-preparation and freeze-thaw cycles. The validated method was utilized to support the pharmacological study of DT-LM in patients with advanced cancer.

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Publisher Full Text (DOI)

Authors+Show Affiliations

Du P
Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing 100021, China.
Han X
Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing 100021, China.
Li N
Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing 100021, China.
Wang H
Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing 100021, China.
Yang S
Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing 100021, China.
Song Y
Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing 100021, China.
Shi Y
Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing 100021, China. Electronic address: syuankai@cicams.ac.cn.

MeSH

Chromatography, High Pressure LiquidDocetaxelDrug StabilityHumansLinear ModelsReproducibility of ResultsSensitivity and SpecificityTandem Mass SpectrometryTaxoidsUltrafiltration

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25063925

Citation

Du, Ping, et al. "Development and Validation of an ultrafiltration-UPLC-MS/MS Method for Rapid Quantification of Unbound Docetaxel in Human Plasma." Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, vol. 967, 2014, pp. 28-35.
Du P, Han X, Li N, et al. Development and validation of an ultrafiltration-UPLC-MS/MS method for rapid quantification of unbound docetaxel in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2014;967:28-35.
Du, P., Han, X., Li, N., Wang, H., Yang, S., Song, Y., & Shi, Y. (2014). Development and validation of an ultrafiltration-UPLC-MS/MS method for rapid quantification of unbound docetaxel in human plasma. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 967, 28-35. https://doi.org/10.1016/j.jchromb.2014.07.007
Du P, et al. Development and Validation of an ultrafiltration-UPLC-MS/MS Method for Rapid Quantification of Unbound Docetaxel in Human Plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2014 Sep 15;967:28-35. PubMed PMID: 25063925.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and validation of an ultrafiltration-UPLC-MS/MS method for rapid quantification of unbound docetaxel in human plasma. AU - Du,Ping, AU - Han,Xiaohong, AU - Li,Ning, AU - Wang,Hongyu, AU - Yang,Sheng, AU - Song,Yuanyuan, AU - Shi,Yuankai, Y1 - 2014/07/14/ PY - 2014/02/13/received PY - 2014/06/25/revised PY - 2014/07/07/accepted PY - 2014/7/27/entrez PY - 2014/7/27/pubmed PY - 2015/5/12/medline KW - Docetaxel lipid microsphere KW - Human plasma KW - UPLC-MS/MS KW - Ultrafiltration KW - Unbound analyte SP - 28 EP - 35 JF - Journal of chromatography. B, Analytical technologies in the biomedical and life sciences JO - J Chromatogr B Analyt Technol Biomed Life Sci VL - 967 N2 - Docetaxel lipid microsphere (DT-LM) is a novel formulation of docetaxel without Tween-80. A sensitive, robust and reproducible ultrafiltration (UF) followed by UPLC-MS/MS method was developed and validated for the quantification of unbound docetaxel in human plasma using paclitaxel as IS. Ultrafiltrate samples were chromatographed on Acquity UPLC BEH C18 column (50 mm × 2.1 mm, 1.7 μm). The mobile phase was a mixture of 10mM ammonium formate in water containing 0.2% formic acid (A) and acetonitrile containing 0.2% formic acid (B). The volume of plasma utilized was only 450 μL. The calibration curve was linear over the range of 0.2-200 ng/mL, with LLOQ of 0.2 ng/mL. The method was shown to be reliable and reproducible with intra- and inter-day precision and accuracy <±15%, and extraction recovery of 98.1-104.8%. Docetaxel was stable during stability studies, e.g., short term, post-preparation and freeze-thaw cycles. The validated method was utilized to support the pharmacological study of DT-LM in patients with advanced cancer. SN - 1873-376X UR - https://www.unboundmedicine.com/medline/citation/25063925/Development_and_validation_of_an_ultrafiltration_UPLC_MS/MS_method_for_rapid_quantification_of_unbound_docetaxel_in_human_plasma_ DB - PRIME DP - Unbound Medicine ER -