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Simultaneous determination of bentysrepinine (Y101) and its metabolites M8 and M9 in human plasma by UPLC-MS/MS and its application to a pharmacokinetic study.
J Pharm Biomed Anal. 2018 Feb 20; 150:287-293.JP

Abstract

A rapid and highly sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for the determination of a novel anti-HBV compound Y101 and its metabolites M8 and M9 in human plasma. The plasma samples were deproteinated with acetonitrile after addition of Peramivir (internal standard, IS) and separated on a 40 °C ACQUITY UPLC BEH C18 column (2.1 mm × 50 mm, 1.7 μm). The mobile phase consisted of water (containing 5 mM ammonium acetate and 0.1% formic acid) and acetonitrile (74:26, v/v) at a flow rate of 0.3 mL/min. The detection was performed on a Triple Quad 5500 tandem mass spectrometer coupled with electrospray ionization (ESI) source in positive mode. Quantification was conducted by multiple reaction monitoring (MRM) of the transitions of m/z 490.1 → 339.0 for Y101, m/z 357.2 → 105.2 for metabolite M8, m/z 373.1 → 105.1 for metabolite M9 and m/z 329.1 → 270.2 for IS, respectively. The method was validated over the calibration curve range of 1.000-1000 ng/mL for Y101, 2.000-2000 ng/mL for metabolite M8 and 0.3000-300.0 ng/mL for metabolite M9, using linear regression and 1/x2 weighting. No matrix effect and carryover effect was observed. The intra- and inter-batch precision and accuracy of Y101, metabolite M8 and M9 were all within the acceptable criteria. This method allows a rapid and simple determination of Y101 and its metabolites M8 and M9 in human plasma. It was successfully applied in a pharmacokinetic study in human for the first time.

Authors+Show Affiliations

Clinical Pharmacology Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou, China.Clinical Pharmacology Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou, China.Clinical Pharmacology Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou, China.Department of Pharmaceutics, College of Pharmaceutical Science, Soochow University, Suzhou, China.Bailing Enterprise Group Pharmaceutical Co., Ltd., Guizhou, China.Bailing Enterprise Group Pharmaceutical Co., Ltd., Guizhou, China.Clinical Pharmacology Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou, China; Department of Pharmaceutics, College of Pharmaceutical Science, Soochow University, Suzhou, China. Electronic address: miaolysuzhou@163.com.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29258048

Citation

Liu, Xiaoxue, et al. "Simultaneous Determination of Bentysrepinine (Y101) and Its Metabolites M8 and M9 in Human Plasma By UPLC-MS/MS and Its Application to a Pharmacokinetic Study." Journal of Pharmaceutical and Biomedical Analysis, vol. 150, 2018, pp. 287-293.
Liu X, Huang C, Xue L, et al. Simultaneous determination of bentysrepinine (Y101) and its metabolites M8 and M9 in human plasma by UPLC-MS/MS and its application to a pharmacokinetic study. J Pharm Biomed Anal. 2018;150:287-293.
Liu, X., Huang, C., Xue, L., Xu, Q., Xia, W., Li, X., & Miao, L. (2018). Simultaneous determination of bentysrepinine (Y101) and its metabolites M8 and M9 in human plasma by UPLC-MS/MS and its application to a pharmacokinetic study. Journal of Pharmaceutical and Biomedical Analysis, 150, 287-293. https://doi.org/10.1016/j.jpba.2017.12.010
Liu X, et al. Simultaneous Determination of Bentysrepinine (Y101) and Its Metabolites M8 and M9 in Human Plasma By UPLC-MS/MS and Its Application to a Pharmacokinetic Study. J Pharm Biomed Anal. 2018 Feb 20;150:287-293. PubMed PMID: 29258048.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Simultaneous determination of bentysrepinine (Y101) and its metabolites M8 and M9 in human plasma by UPLC-MS/MS and its application to a pharmacokinetic study. AU - Liu,Xiaoxue, AU - Huang,Chenrong, AU - Xue,Ling, AU - Xu,Qingqing, AU - Xia,Wen, AU - Li,Xing, AU - Miao,Liyan, Y1 - 2017/12/13/ PY - 2017/06/10/received PY - 2017/12/06/revised PY - 2017/12/06/accepted PY - 2017/12/20/pubmed PY - 2018/8/7/medline PY - 2017/12/20/entrez KW - Anti-HBV KW - Human plasma KW - Pharmacokinetics KW - UPLC–MS/MS KW - Y101 SP - 287 EP - 293 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 150 N2 - A rapid and highly sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for the determination of a novel anti-HBV compound Y101 and its metabolites M8 and M9 in human plasma. The plasma samples were deproteinated with acetonitrile after addition of Peramivir (internal standard, IS) and separated on a 40 °C ACQUITY UPLC BEH C18 column (2.1 mm × 50 mm, 1.7 μm). The mobile phase consisted of water (containing 5 mM ammonium acetate and 0.1% formic acid) and acetonitrile (74:26, v/v) at a flow rate of 0.3 mL/min. The detection was performed on a Triple Quad 5500 tandem mass spectrometer coupled with electrospray ionization (ESI) source in positive mode. Quantification was conducted by multiple reaction monitoring (MRM) of the transitions of m/z 490.1 → 339.0 for Y101, m/z 357.2 → 105.2 for metabolite M8, m/z 373.1 → 105.1 for metabolite M9 and m/z 329.1 → 270.2 for IS, respectively. The method was validated over the calibration curve range of 1.000-1000 ng/mL for Y101, 2.000-2000 ng/mL for metabolite M8 and 0.3000-300.0 ng/mL for metabolite M9, using linear regression and 1/x2 weighting. No matrix effect and carryover effect was observed. The intra- and inter-batch precision and accuracy of Y101, metabolite M8 and M9 were all within the acceptable criteria. This method allows a rapid and simple determination of Y101 and its metabolites M8 and M9 in human plasma. It was successfully applied in a pharmacokinetic study in human for the first time. SN - 1873-264X UR - https://www.unboundmedicine.com/medline/citation/29258048/Simultaneous_determination_of_bentysrepinine__Y101__and_its_metabolites_M8_and_M9_in_human_plasma_by_UPLC_MS/MS_and_its_application_to_a_pharmacokinetic_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(17)31489-9 DB - PRIME DP - Unbound Medicine ER -