Validation of warfarin enantiomer analysis method in plasma using high-performance liquid chromatography fluorescence detector.

Autor: Putriana NA; Department of Pharmaceutics and Pharmaceutical Technology, Universitas Padjadjaran, Jalan Raya Bandung-Sumedang, Jatinangor, Indonesia., Rusdiana T; Department of Pharmaceutics and Pharmaceutical Technology, Universitas Padjadjaran, Jalan Raya Bandung-Sumedang, Jatinangor, Indonesia., Rostinawati T; Department of Biology Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Jalan Raya Bandung-Sumedang, Jatinangor, Indonesia., Akbar MR; Department of Cardiovascular, Faculty of Medicine, Universitas Padjadjaran, Jalan Raya Bandung-Sumedang, Jatinangor, Indonesia., Saputri FA; Department of Laboratory of Pharmaceutical-Medicinal Chemistry and Bioanalysis, Faculty of Pharmacy, Universitas Indonesia, Depok, Indonesia., Utami S; Department of Pharmaceutics and Pharmaceutical Technology, Universitas Padjadjaran, Jalan Raya Bandung-Sumedang, Jatinangor, Indonesia.
Jazyk: angličtina
Zdroj: Journal of advanced pharmaceutical technology & research [J Adv Pharm Technol Res] 2022 Jan-Mar; Vol. 13 (1), pp. 18-24. Date of Electronic Publication: 2022 Jan 21.
DOI: 10.4103/japtr.japtr_259_21
Abstrakt: Warfarin (WF) is an anticoagulant commonly used for thromboembolism-related diseases. This study aims to assess the pharmacokinetic profile of WF. The stereospecific interaction of S-and R-WF requires quantification of the enantiomer to determine the pharmacokinetic profile. The analysis method of the enantiomers in plasma is developed using an HPLC fluorescence detector with a Chiralcel OD-RH column (4.6 mm × 150 mm i.d., 5 m) and a Chiralcel OD-RH guard column (4.0 mm × 10 mm, 5 m). The separation is conducted using isocratic with acetonitrile mobile phase: Phosphate buffer, pH 2.00 (40:60 v/v), column temperature 40°C, flow rate 1 mL/min, injection volume 50 L. WF is measured at an excitation wavelength of 310 nm and emission of 350 nm. This method results in limit of detection (LOD) values of 18.6 ng/mL and limit of quantitation (LOQ) of 62.01 ng/mL for R-WF and LOD values of 18.61 ng/mL and LOQ of 62.04 ng/mL for S-WF. The results showed a linearity in concentration between 100 and 2500 ng/mL with r 2 = 0.9969 and r 2 = 0.9991 for R-and S-WF. The validation requirements of selectivity, accuracy, and precision for within and between run with a value of <15% for % relative standard deviation and % diff were achieved. This method can be used in the sample measurement of WF pharmacokinetic studies.
Competing Interests: There are no conflicts of interest.
(Copyright: © 2022 Journal of Advanced Pharmaceutical Technology & Research.)
Databáze: MEDLINE
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