Tags

Type your tag names separated by a space and hit enter

Application of a UPLC-MS/MS method for the analysis of alosetron in human plasma to support a bioequivalence study in healthy males and females.
Biomed Chromatogr. 2015 Oct; 29(10):1527-34.BC

Abstract

A simple, rapid and sensitive ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method has been developed and validated for the determination of alosetron (ALO) in human plasma. The assay method involved solid-phase extraction of ALO and ALO 13C-d3 as internal standard (IS) on a LichroSep DVB-HL (30 mg, 1 cm(3)) cartridge. The chromatography was performed on an Acquity UPLC BEH C18 (50 × 2.1 mm, 1.7 µm) column using acetonitrile and 2.0 mm ammonium formate, pH 3.0 adjusted with 0.1% formic acid (80:20, v/v) as the mobile phase in an isocratic mode. For quantitative analysis, the multiple reaction monitoring transitions studied were m/z 295.1/201.0 for ALO and m/z 299.1/205.1 for IS in the positive ionization mode. The method was validated over a concentration range of 0.01-10.0 ng/mL for ALO. Post-column infusion experiment showed no positive or negative peaks in the elution range of the analyte and IS after injection of extracted blank plasma. The extent of ion-suppression/enhancement, expressed as IS-normalized matrix factor, varied from 0.96 to 1.04. The assay recovery was within 97-103% for ALO and IS. The method was successfully applied to support a bioequivalence study of 1.0 mg alosetron tablets in 28 healthy Indian male and female subjects.

Links

Publisher Full Text (DOI)

Authors+Show Affiliations

Department of Chemistry, School of Sciences, Gujarat University, Ahmedabad, 380009, Gujarat, India.

Department of Chemistry, School of Sciences, Gujarat University, Ahmedabad, 380009, Gujarat, India.

Department of Chemistry, School of Sciences, Gujarat University, Ahmedabad, 380009, Gujarat, India.

Department of Chemistry, School of Sciences, Gujarat University, Ahmedabad, 380009, Gujarat, India.

Department of Chemistry, St Xavier's College, Navrangpura, Ahmedabad, 380009, Gujarat, India.

Department of Chemistry, School of Sciences, Gujarat University, Ahmedabad, 380009, Gujarat, India.

MeSH

AdolescentAdultCalibrationCarbolinesChromatography, High Pressure LiquidCross-Over StudiesFemaleHealthy VolunteersHumansMaleMiddle AgedReproducibility of ResultsSolid Phase ExtractionTandem Mass SpectrometryTherapeutic EquivalencyYoung Adult

Pub Type(s)

Journal Article

Language

eng

PubMed ID

25761551

Citation

Chaudhary, Darshan V., et al. "Application of a UPLC-MS/MS Method for the Analysis of Alosetron in Human Plasma to Support a Bioequivalence Study in Healthy Males and Females." Biomedical Chromatography : BMC, vol. 29, no. 10, 2015, pp. 1527-34.

Chaudhary DV, Patel DP, Shah JV, et al. Application of a UPLC-MS/MS method for the analysis of alosetron in human plasma to support a bioequivalence study in healthy males and females. Biomed Chromatogr. 2015;29(10):1527-34.

Chaudhary, D. V., Patel, D. P., Shah, J. V., Shah, P. A., Sanyal, M., & Shrivastav, P. S. (2015). Application of a UPLC-MS/MS method for the analysis of alosetron in human plasma to support a bioequivalence study in healthy males and females. Biomedical Chromatography : BMC, 29(10), 1527-34. https://doi.org/10.1002/bmc.3454

Chaudhary DV, et al. Application of a UPLC-MS/MS Method for the Analysis of Alosetron in Human Plasma to Support a Bioequivalence Study in Healthy Males and Females. Biomed Chromatogr. 2015;29(10):1527-34. PubMed PMID: 25761551.

* Article titles in AMA citation format should be in sentence-case

TY - JOUR T1 - Application of a UPLC-MS/MS method for the analysis of alosetron in human plasma to support a bioequivalence study in healthy males and females. AU - Chaudhary,Darshan V, AU - Patel,Daxesh P, AU - Shah,Jaivik V, AU - Shah,Priyanka A, AU - Sanyal,Mallika, AU - Shrivastav,Pranav S, Y1 - 2015/03/11/ PY - 2014/12/16/received PY - 2015/01/20/revised PY - 2015/01/30/accepted PY - 2015/3/13/entrez PY - 2015/3/13/pubmed PY - 2016/6/15/medline KW - Alosetron KW - UPLC-MS/MS KW - gender effects on pharmacokinetics KW - high throughput KW - solid phase extraction SP - 1527 EP - 34 JF - Biomedical chromatography : BMC JO - Biomed Chromatogr VL - 29 IS - 10 N2 - A simple, rapid and sensitive ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method has been developed and validated for the determination of alosetron (ALO) in human plasma. The assay method involved solid-phase extraction of ALO and ALO 13C-d3 as internal standard (IS) on a LichroSep DVB-HL (30 mg, 1 cm(3)) cartridge. The chromatography was performed on an Acquity UPLC BEH C18 (50 × 2.1 mm, 1.7 µm) column using acetonitrile and 2.0 mm ammonium formate, pH 3.0 adjusted with 0.1% formic acid (80:20, v/v) as the mobile phase in an isocratic mode. For quantitative analysis, the multiple reaction monitoring transitions studied were m/z 295.1/201.0 for ALO and m/z 299.1/205.1 for IS in the positive ionization mode. The method was validated over a concentration range of 0.01-10.0 ng/mL for ALO. Post-column infusion experiment showed no positive or negative peaks in the elution range of the analyte and IS after injection of extracted blank plasma. The extent of ion-suppression/enhancement, expressed as IS-normalized matrix factor, varied from 0.96 to 1.04. The assay recovery was within 97-103% for ALO and IS. The method was successfully applied to support a bioequivalence study of 1.0 mg alosetron tablets in 28 healthy Indian male and female subjects. SN - 1099-0801 UR - https://www.unboundmedicine.com/medline/citation/25761551/Application_of_a_UPLC_MS/MS_method_for_the_analysis_of_alosetron_in_human_plasma_to_support_a_bioequivalence_study_in_healthy_males_and_females_ DB - PRIME DP - Unbound Medicine ER -