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Novel and sensitive UPLC-MS/MS method for quantification of sofosbuvir in human plasma: application to a bioequivalence study.
Biomed Chromatogr. 2016 Sep; 30(9):1354-62.BC

Abstract

A novel and sensitive LC-MS/MS method was developed and validated for determination of sofosbuvir (SF) using eplerenone as an internal standard. The Xevo TQD LC-MS/MS was operated under the multiple-reaction monitoring mode using electrospray ionization. Extraction with tert-butyl methyl ether was used in sample preparation. The prepared samples were chromatographed on Acquity UPLC BEH C18 (50 × 2.1 mm, 1.7 μm) column by pumping 0.1% formic acid and acetonitrile in an isocratic mode at a flow rate of 0.35 mL/min. Method validation was performed as per the US Food and Drug Administration guidelines and the standard curves were found to be linear in the range of 0.25-3500 ng/mL for SF. The intra- and inter-day precision and accuracy results were within the acceptable limits. A very short run time of 1 min made it possible to analyze more than 500 human plasma samples per day. A very low quantification limit of SF allowed the applicability of the developed method for determination of SF in a bioequivalence study in human volunteers. Copyright © 2016 John Wiley & Sons, Ltd.

Authors+Show Affiliations

Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, 11562, Cairo, Egypt.Pharmaceutics and Industrial Pharmacy Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, 11562, Cairo, Egypt.Advanced Research Center, Nasr City, Cairo, Egypt.

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

26821881

Citation

Rezk, Mamdouh R., et al. "Novel and Sensitive UPLC-MS/MS Method for Quantification of Sofosbuvir in Human Plasma: Application to a Bioequivalence Study." Biomedical Chromatography : BMC, vol. 30, no. 9, 2016, pp. 1354-62.
Rezk MR, Basalious EB, Amin ME. Novel and sensitive UPLC-MS/MS method for quantification of sofosbuvir in human plasma: application to a bioequivalence study. Biomed Chromatogr. 2016;30(9):1354-62.
Rezk, M. R., Basalious, E. B., & Amin, M. E. (2016). Novel and sensitive UPLC-MS/MS method for quantification of sofosbuvir in human plasma: application to a bioequivalence study. Biomedical Chromatography : BMC, 30(9), 1354-62. https://doi.org/10.1002/bmc.3690
Rezk MR, Basalious EB, Amin ME. Novel and Sensitive UPLC-MS/MS Method for Quantification of Sofosbuvir in Human Plasma: Application to a Bioequivalence Study. Biomed Chromatogr. 2016;30(9):1354-62. PubMed PMID: 26821881.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Novel and sensitive UPLC-MS/MS method for quantification of sofosbuvir in human plasma: application to a bioequivalence study. AU - Rezk,Mamdouh R, AU - Basalious,Emad B, AU - Amin,Mohammed E, Y1 - 2016/02/16/ PY - 2015/11/30/received PY - 2016/01/16/revised PY - 2016/01/25/accepted PY - 2016/1/30/entrez PY - 2016/1/30/pubmed PY - 2017/2/9/medline KW - UPLC-MS/MS KW - bioequivalence KW - plasma KW - sofosbuvir KW - validation SP - 1354 EP - 62 JF - Biomedical chromatography : BMC JO - Biomed. Chromatogr. VL - 30 IS - 9 N2 - A novel and sensitive LC-MS/MS method was developed and validated for determination of sofosbuvir (SF) using eplerenone as an internal standard. The Xevo TQD LC-MS/MS was operated under the multiple-reaction monitoring mode using electrospray ionization. Extraction with tert-butyl methyl ether was used in sample preparation. The prepared samples were chromatographed on Acquity UPLC BEH C18 (50 × 2.1 mm, 1.7 μm) column by pumping 0.1% formic acid and acetonitrile in an isocratic mode at a flow rate of 0.35 mL/min. Method validation was performed as per the US Food and Drug Administration guidelines and the standard curves were found to be linear in the range of 0.25-3500 ng/mL for SF. The intra- and inter-day precision and accuracy results were within the acceptable limits. A very short run time of 1 min made it possible to analyze more than 500 human plasma samples per day. A very low quantification limit of SF allowed the applicability of the developed method for determination of SF in a bioequivalence study in human volunteers. Copyright © 2016 John Wiley & Sons, Ltd. SN - 1099-0801 UR - https://www.unboundmedicine.com/medline/citation/26821881/Novel_and_sensitive_UPLC_MS/MS_method_for_quantification_of_sofosbuvir_in_human_plasma:_application_to_a_bioequivalence_study_ L2 - https://doi.org/10.1002/bmc.3690 DB - PRIME DP - Unbound Medicine ER -