Validation and application of HPLC–ESI–MS/MS method for the determination of irsogladine

• Autorzy: Hoang N. H. , Huong N. L. , Hong S.-Y. , Park J.-W

Identyfikatory

DOI

10.1556/1326.2017.00024

• Języki publikacji: EN

Abstrakty

EN

A highly sensitive analytical tool for the fast quantification of irsogladine in human plasma was developed. Cleanup using a solid-phase extraction technique is a simple method for extracting both irsogladine and lamotrigine (internal standard) spiked into human plasma. The resolvable separation of both analytes through reversed-phase high-performance liquid chromatography (HPLC) was carried out within 5 min. The HPLC–electrospray ionization (ESI)–tandem mass spectrometry (MS/MS) method, which was operated in a selected reaction monitoring mode specific to the target analytes, was verified for use in the quantification of irsogladine. The inter- and intra-day precision (relative standard deviation, RSD) of irsogladine spiked into quality control samples were <7%, and their accuracies were between 96.6% and 102.1%. The calibration curve for irsogladine spiked into human plasma was linear over the range from 1.8 to 100 ng mL−1 with lower limit of quantification at 1.8 ng Ml^-1. The established method was successfully applied for a bioequivalence study of irsogladine.

Słowa kluczowe

EN

Irsogladine; human plasma; HPLC-ESI-MS/MS; bioequivalence study

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2017
• Tom: Vol. 29, no. 4
• Strony: 459--462
• Opis fizyczny: Bibliogr. 10 poz., rys.

Twórcy

autor

Hoang N. H.

• Department of BT Convergent Pharmaceutical Engineering, SunMoon University, Chungnam 31460, Republic of Korea

autor

Huong N. L.

• Department of BT Convergent Pharmaceutical Engineering, SunMoon University, Chungnam 31460, Republic of Korea

autor

Hong S.-Y.

• School of Biosystem and Biomedical Science, Korea University, Seoul 02841, Republic of Korea

autor

Park J.-W

• School of Biosystem and Biomedical Science, Korea University, Seoul 02841, Republic of Korea

Bibliografia

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• [8] Guidance for Industry: Bioanalytical Method Validation, U.S. Department of Health and Human Services, Food and Drug Administration, 2001, Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368107.pdf. Accessed April 18, 2016.
• [9] Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Consideration. U.S. Department of Health and Human Services, Food and Drug Administration, 2001.
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Uwagi

PL

Opracowanie rekordu w ramach umowy 509/P-DUN/2018 ze środków MNiSW przeznaczonych na działalność upowszechniającą naukę (2018).