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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

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

Acta Chromatographica

2021

Vol. 33, no. 4

309--314

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.

Validated TLC method for simultaneous quantitation of atorvastatin, ezetimibe, and fenofibrate in bulk drug and formulations

Nikalje A. G, Choudhari V. P

Acta Chromatographica

2011

Vol. 23, no. 2

267--280

This article describes a new, simple, precise and accurate TLC method for simultaneous quantitation of atorvastatin (ATO), ezetimibe (EZE), and fenofibrate (FEN) as the bulk drug and in tablet dosage forms. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisting of chloroform-toluene-methanol-acetic acid 6:3:0.5:0.15 (υ/υ/υ/υ). Densitometric evaluation of the separated zones was performed at 263 nm. The drugs were satisfactorily resolved with RF values of 0.16 ± 0.02, 0.22 ± 0.02, and 0.76 ± 0.02 for ATO, EZE, and FEN, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (75–375 ng per spot for ATO, 99–594 ng per spot for EZE, and 66–330 ng per spot for FEN), precision intra-day and inter-day RSD values were always less than 1.51 for the titled drugs, accuracy (99.72 ± 0.75% for ATO, 101.25 ± 0.91% for EZE, and 101.06 ± 0.60% for FEN), and specificity, in accordance with ICH guidelines.