Development and validation of a rapid UHPLCMS/MS method for the determination of fenofibric acid in human plasma: application to a pharmacokinetic study of fenofibrate tablet in Chinese subjects

• Autorzy: Wu Xiaorong , Wang Yankai , Liang Binbin , Wu Honghai , Wu Liying , Song Jing , Liu Jianfang

Identyfikatory

DOI

10.1556/1326.2020.00792

• Języki publikacji: EN

Abstrakty

EN

An ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC–MS/MS) method was developed to determine the fenofibric acid (FA) in human plasma and applied to a pharmacokinetic study of fenofibrate tablet (Lipanthyl® supra, 160 mg) on Chinese subjects which had not been reported. Bezafibrate was used as an internal standard (IS), and the plasma samples were precipitated by methanol. Multiple reaction monitoring (MRM) mode was used to quantitatively analyzed FA m/z 317.2→230.7 and the IS m/z 360.0→274.0 in the electrospray ionization (ESI) negative interface. The calibration curves were linear over the range of 50–30,000 ng/mL (r² ≥ 0.996). The intra-day and interday precision (coefficient of variation, CV%) was less than 2.7 and 2.5%, respectively. The accuracy (relative error, RE%) ranged from 4.5 to 6.9%. The average recovery was higher than 86.2%, and the matrix effect was between 95.32 and 110.55%. The simple, rapid, and selectivity method was successfully applied to the pharmacokinetic study of fenofibrate tablets on Chinese subjects.

Słowa kluczowe

EN

UHPLC-MS/MS; fenofibrate; fenofibric acid; pharmacokinetic study

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2021
• Tom: Vol. 33, no. 4
• Strony: 309--314
• Opis fizyczny: Bibliogr. 19 poz., rys., tab.

Twórcy

autor

Wu Xiaorong

• Bethune International Peace Hospital, No. 398 Zhongshan West Road, Shijiazhuang 050081, China

autor

Wang Yankai

• Shijiazhuang Maternity Hospital, No. 206 Zhongshan East Road, Shijiazhuang 050081, China

autor

Liang Binbin

• China Pharmaceutical University, No. 639 Longmian Road, Nanjing 211198, China

autor

Wu Honghai

• Bethune International Peace Hospital, No. 398 Zhongshan West Road, Shijiazhuang 050081, China

autor

Wu Liying

• Bethune International Peace Hospital, No. 398 Zhongshan West Road, Shijiazhuang 050081, China

autor

Song Jing

• Bethune International Peace Hospital, No. 398 Zhongshan West Road, Shijiazhuang 050081, China

autor

Liu Jianfang

• Bethune International Peace Hospital, No. 398 Zhongshan West Road, Shijiazhuang 050081, China

• https://orcid.org/0000-0001-8325-0360

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