Development and validation of a HPLC-MS/MS assay for the determination of lutein concentration in human and rat plasma

• Autorzy: Zhao Xiuli , Wang Shumin , Zhou Hui , Guo Shaojie , Ni Siyang , Yang Bo , Zhang Lihua , Xu Xinde

Identyfikatory

DOI

10.1556/1326.2017.00313

• Języki publikacji: EN

Abstrakty

EN

The aim of this study was to develop and validate a HPLC-MS/MS assay to determine the lutein concentration in plasma samples of human and SD rats. Organic solvent was used for lutein extraction. The extract was injected into a HPLC-MS/MS system. Reversed phase chromatography was performed on a C18 column in gradient mode. Lutein and internal standard (phenytoin sodium) were identified in atmospheric pressure chemical ionization mode using ion transitions of m/z 567.5>549.4 and 205.2>110.8, respectively. The lutein quantification assay was linear over concentrations ranging from 4 to 500 ng/mL. The lower limit of quantification was 4 ng/mL with satisfactory precision and accuracy. The assay presented acceptable intra and inter-batch precision (RSD%) and accuracy (RE%) <8.16% in SD rat plasma and <12.80% in human plasma. The extraction recovery ranged from 50.94 to 60.90% in SD rat plasma and 68.73% in human plasma. The matrix effect for lutein was acceptable and had minimal influence on the results. The method was then applied to determine the lutein concentrations in human plasma after a single oral dose of 20mg lutein. The method described is rapid, selective, sensitive and reproducible. This method can be used for both pharmacokinetic studies and therapeutic drug monitoring purposes.

Słowa kluczowe

EN

Lutein; HPLC-MS/MS; Plasma concentration; Pharmacokinetics

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2019
• Tom: Vol. 31, no. 1
• Strony: 19--22
• Opis fizyczny: Bibliogr. 15 poz., rys., tab.

Twórcy

autor bibliografii

Wu Feng

• National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University, Beijing-100730, China

autor

Zhao Xiuli

• National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University, Beijing-100730, China

autor

Wang Shumin

• National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University, Beijing-100730, China

autor

Zhou Hui

• National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University, Beijing-100730, China

autor

Guo Shaojie

• National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University, Beijing-100730, China

autor

Ni Siyang

• National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University, Beijing-100730, China

autor

Yang Bo

• National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University, Beijing-100730, China

autor

Zhang Lihua

• Zhejiang Medicine Co. Ltd, Xinchang Pharma. Factory, Zhejiang Xinchang-312500, China

autor

Xu Xinde

• Zhejiang Medicine Co. Ltd, Xinchang Pharma. Factory, Zhejiang Xinchang-312500, China

Bibliografia

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• [9] Schalch, W.; Cohn, W.; Barker, F. M.; Kõpcke, W.; Mellerio, J.; Bird, A. C.; Robson, A. G.; Fitzke, F. F.; van Kuijk, Arch. Biochem. Biophys. 2007, 458, 128–135.
• [10] Obana, A.; Tanito, M.; Gohto, Y.; Okazaki, S.; Gellermann, W.; Bernstein, P. S. PLoS One 2015, 10, e0139257.
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• [13] Sato, Y.; Kobayashi, M.; Itagaki, S.; Hirano, T.; Noda, T.; Mizuno, S.; Sugawara, M.; Iseki, K. Biopharm. Drug Dispos. 2011, 32, 151–158.
• [14] Sowmya, P. R.; Arathi, B. P.; Vijay, K.; Baskaran, V.; Lakshminarayana, R. Chromatographia 2014, 77, 1633–1642.
• [15] Guidance for Industry: Bioanalytical Method Validation, U.S. Department of Health and Human Service, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Centre for Veterinary Medicine (CVM), May 2001.

Uwagi

PL

Opracowanie rekordu w ramach umowy 509/P-DUN/2018 ze środków MNiSW przeznaczonych na działalność upowszechniającą naukę (2019).