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Evaluation of a rapid method for the simultaneous quantification of ribavirin, sofosbuvir and its metabolite in rat plasma by UPLC-MS/MS.

Abstract

A rapid and sensitive ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method for the determination of ribavirin, sofosbuvir and its metabolite GS-331007 in rat plasma was established. The analytes and the internal standard (midazolam) 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 245.1→113.1 for ribavirin, m/z 530.3→243.1 for sofosbuvir, m/z 261.5→113.1 for GS-331007 and m/z 326.2→291.1 for midazolam (IS) using a positive electrospray ionization interface. The method was validated over a concentration range of 5-1000ng/mL for ribavirin, 10-2000ng/mL for sofosbuvir and 10-2000ng/mL for GS-331007. Total time for each chromatograph 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) <10.0% and the accuracy values ranged from -10.6% to 11.6%. The method was successfully applied to a pharmacokinetic study of ribavirin, sofosbuvir and GS-331007 in rats.

Authors+Show Affiliations

Department of Hepatopathy, Ningbo No.2 Hospital, Ningbo 315000, China.Department of Hepatopathy, Ningbo No.2 Hospital, Ningbo 315000, China.Digestive Department, Ningbo No.2 Hospital, Ningbo 315000, China.Pharmaceutical Preparation Section, Ningbo No.2 Hospital, Ningbo 315000, China.Department of Hepatopathy, Ningbo No.2 Hospital, Ningbo 315000, China. Electronic address: 21466738@qq.com.Department of Paediatrics, Ningbo Women and Children's Hospital, Ningbo 315000, China. Electronic address: 109315536@qq.com.

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

26363369

Citation

Shi, Xiaojun, et al. "Evaluation of a Rapid Method for the Simultaneous Quantification of Ribavirin, Sofosbuvir and Its Metabolite in Rat Plasma By UPLC-MS/MS." Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, vol. 1002, 2015, pp. 353-7.
Shi X, Zhu D, Lou J, et al. Evaluation of a rapid method for the simultaneous quantification of ribavirin, sofosbuvir and its metabolite in rat plasma by UPLC-MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci. 2015;1002:353-7.
Shi, X., Zhu, D., Lou, J., Zhu, B., Hu, A. R., & Gan, D. (2015). Evaluation of a rapid method for the simultaneous quantification of ribavirin, sofosbuvir and its metabolite in rat plasma by UPLC-MS/MS. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 1002, pp. 353-7. doi:10.1016/j.jchromb.2015.08.038.
Shi X, et al. Evaluation of a Rapid Method for the Simultaneous Quantification of Ribavirin, Sofosbuvir and Its Metabolite in Rat Plasma By UPLC-MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci. 2015 Oct 1;1002:353-7. PubMed PMID: 26363369.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of a rapid method for the simultaneous quantification of ribavirin, sofosbuvir and its metabolite in rat plasma by UPLC-MS/MS. AU - Shi,Xiaojun, AU - Zhu,Dedong, AU - Lou,Jie, AU - Zhu,Bo, AU - Hu,Ai-rong, AU - Gan,Dongmei, Y1 - 2015/08/30/ PY - 2015/07/09/received PY - 2015/08/23/revised PY - 2015/08/25/accepted PY - 2015/9/13/entrez PY - 2015/9/13/pubmed PY - 2016/5/18/medline KW - GS-331007 KW - Pharmacokinetics KW - Plasma KW - Ribavirin KW - Sofosbuvir KW - UPLC–MS/MS SP - 353 EP - 7 JF - Journal of chromatography. B, Analytical technologies in the biomedical and life sciences JO - J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. VL - 1002 N2 - A rapid and sensitive ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method for the determination of ribavirin, sofosbuvir and its metabolite GS-331007 in rat plasma was established. The analytes and the internal standard (midazolam) 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 245.1→113.1 for ribavirin, m/z 530.3→243.1 for sofosbuvir, m/z 261.5→113.1 for GS-331007 and m/z 326.2→291.1 for midazolam (IS) using a positive electrospray ionization interface. The method was validated over a concentration range of 5-1000ng/mL for ribavirin, 10-2000ng/mL for sofosbuvir and 10-2000ng/mL for GS-331007. Total time for each chromatograph 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) <10.0% and the accuracy values ranged from -10.6% to 11.6%. The method was successfully applied to a pharmacokinetic study of ribavirin, sofosbuvir and GS-331007 in rats. SN - 1873-376X UR - https://www.unboundmedicine.com/medline/citation/26363369/Evaluation_of_a_rapid_method_for_the_simultaneous_quantification_of_ribavirin_sofosbuvir_and_its_metabolite_in_rat_plasma_by_UPLC_MS/MS_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1570-0232(15)30166-5 DB - PRIME DP - Unbound Medicine ER -