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Simultaneous determination of ledipasvir, sofosbuvir and its metabolite in rat plasma by UPLC-MS/MS and its application to a pharmacokinetic study.
J Chromatogr B Analyt Technol Biomed Life Sci. 2016 Jan 01; 1008:255-259.JC

Abstract

In this work, a rapid and sensitive ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method for the determination of ledipasvir, sofosbuvir and its metabolite GS-331007 in rat plasma was developed. The analytes and the internal standard (diazepam) were separated on an Acquity UPLC BEH C18 chromatography column (2.1mm×50mm, 1.7μm) using gradient elution with a mobile phase of acetonitrile and 0.1% formic acid in water at a flow rate of 0.4mL/min. The detection was performed on a triple quadrupole tandem mass spectrometer by multiple reaction monitoring (MRM) mode to monitor the precursor-to-product ion transitions of m/z 889.8→130.1 for ledipasvir, m/z 530.3→243.1 for sofosbuvir, m/z 261.5→113.1 for GS-331007 and m/z 285.2→193.1 for diazepam (IS) using a positive electrospray ionization interface. The method was validated over a concentration range of 2-500ng/mL for ledipasvir, 10-2000ng/mL for sofosbuvir and 10-2000ng/mL for GS-331007. Total time for each chromatography was 3.0min. The intra- and inter-day precision and accuracy of the quality control samples at low, medium, and high concentration levels exhibited relative standard deviations (RSD)<10.2% and the accuracy values ranged from -9.8% to 11.2%. The method was successfully applied to a pharmacokinetic study of ledipasvir, sofosbuvir and GS-331007 in rats.

Authors+Show Affiliations

The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, China.Wenzhou People's Hospital, Wenzhou 325027, China.The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China. Electronic address: linwei196061@163.com.The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, China. Electronic address: wzzhenzhenpan@126.com.

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

26684720

Citation

Pan, Chenwei, et al. "Simultaneous Determination of Ledipasvir, Sofosbuvir and Its Metabolite in Rat Plasma By UPLC-MS/MS and Its Application to a Pharmacokinetic Study." Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, vol. 1008, 2016, pp. 255-259.
Pan C, Chen Y, Chen W, et al. Simultaneous determination of ledipasvir, sofosbuvir and its metabolite in rat plasma by UPLC-MS/MS and its application to a pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci. 2016;1008:255-259.
Pan, C., Chen, Y., Chen, W., Zhou, G., Jin, L., Zheng, Y., Lin, W., & Pan, Z. (2016). Simultaneous determination of ledipasvir, sofosbuvir and its metabolite in rat plasma by UPLC-MS/MS and its application to a pharmacokinetic study. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 1008, 255-259. https://doi.org/10.1016/j.jchromb.2015.11.056
Pan C, et al. Simultaneous Determination of Ledipasvir, Sofosbuvir and Its Metabolite in Rat Plasma By UPLC-MS/MS and Its Application to a Pharmacokinetic Study. J Chromatogr B Analyt Technol Biomed Life Sci. 2016 Jan 1;1008:255-259. PubMed PMID: 26684720.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Simultaneous determination of ledipasvir, sofosbuvir and its metabolite in rat plasma by UPLC-MS/MS and its application to a pharmacokinetic study. AU - Pan,Chenwei, AU - Chen,Yongping, AU - Chen,Weilai, AU - Zhou,Guangyao, AU - Jin,Lingxiang, AU - Zheng,Yi, AU - Lin,Wei, AU - Pan,Zhenzhen, Y1 - 2015/12/03/ PY - 2015/07/05/received PY - 2015/11/27/revised PY - 2015/11/30/accepted PY - 2015/12/20/entrez PY - 2015/12/20/pubmed PY - 2016/8/12/medline KW - GS-331007 KW - Ledipasvir KW - Pharmacokinetics KW - Plasma KW - Sofosbuvir KW - UPLC–MS/MS SP - 255 EP - 259 JF - Journal of chromatography. B, Analytical technologies in the biomedical and life sciences JO - J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. VL - 1008 N2 - In this work, a rapid and sensitive ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method for the determination of ledipasvir, sofosbuvir and its metabolite GS-331007 in rat plasma was developed. The analytes and the internal standard (diazepam) were separated on an Acquity UPLC BEH C18 chromatography column (2.1mm×50mm, 1.7μm) using gradient elution with a mobile phase of acetonitrile and 0.1% formic acid in water at a flow rate of 0.4mL/min. The detection was performed on a triple quadrupole tandem mass spectrometer by multiple reaction monitoring (MRM) mode to monitor the precursor-to-product ion transitions of m/z 889.8→130.1 for ledipasvir, m/z 530.3→243.1 for sofosbuvir, m/z 261.5→113.1 for GS-331007 and m/z 285.2→193.1 for diazepam (IS) using a positive electrospray ionization interface. The method was validated over a concentration range of 2-500ng/mL for ledipasvir, 10-2000ng/mL for sofosbuvir and 10-2000ng/mL for GS-331007. Total time for each chromatography was 3.0min. The intra- and inter-day precision and accuracy of the quality control samples at low, medium, and high concentration levels exhibited relative standard deviations (RSD)<10.2% and the accuracy values ranged from -9.8% to 11.2%. The method was successfully applied to a pharmacokinetic study of ledipasvir, sofosbuvir and GS-331007 in rats. SN - 1873-376X UR - https://www.unboundmedicine.com/medline/citation/26684720/Simultaneous_determination_of_ledipasvir_sofosbuvir_and_its_metabolite_in_rat_plasma_by_UPLC_MS/MS_and_its_application_to_a_pharmacokinetic_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1570-0232(15)30324-X DB - PRIME DP - Unbound Medicine ER -