期刊
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
卷 194, 期 -, 页码 -出版社
ELSEVIER
DOI: 10.1016/j.jpba.2020.113758
关键词
Flavoxate; 3-methyl-flavone-8-carboxylic acid; LC-MSMS; Hydrolysis degradation; Bioequivalence study
资金
- Y.S.P. Industries (M) Sdn. Bhd.
A simple, rapid, sensitive, and reproducible LC-MS/MS method was developed for simultaneous quantification of flavoxate and MFCA in human plasma. The method showed high accuracy and stability, and was successfully applied to a bioequivalence study.
A simple, rapid, sensitive, and reproducible LC-MS/MS method was developed for simultaneous quantification of flavoxate and 3-methyl-flavone-8-carboxylic (MFCA) in human plasma, using diphenhydramine HCl as internal standard (IS). The chromatographic separation was achieved using Agilent Poroshell 120 EC-C18 - Fast LC column (100 x 2.1mmID, 2.7 mu m) fitted with UHPLC Guard Poroshell 120 EC-C18 (5 x 2.1 mmID, 2.7 mu m). The mobile phase consisted of 0.1 % v/v formic acid and acetonitrile (30:70, v/v) run at a flow rate of 0.40 mL/min. The standard calibration curve was linear over the concentration range of 2.00 - 2,000.31 ng/mL and 240.00 - 24,000.04 ng/mL for flavoxate and MFCA. For flavoxate and MFCA, the within-run precision was 0.81-6.67 % and 1.68-4.37 %, while accuracy was 100.21-108.25 % and 103.99-110.28 %. The between-run precision was 2.01-9.14 % and 2.31-11.11 %, and accuracy was 96.09-103.33 % and 102.37-109.52 %. The extended run precision was 7.78-11.04 % and 2.22-3.33 %, while accuracy was 100.72-101.88 % and 102.34-105.60 %. Flavoxate and MFCA in plasma were stable 4 h at bench top (short term), 24 h in autosampler and instrumentation room (post-preparative), after 7 freeze-thaw cycles, and 89 days in the freezer. Both analytes and IS stock solutions were stable for 31 days when kept at room temperature (25 +/- ( )4 degrees C) and refrigerated (2-8 degrees C). The validated method was successfully applied to a bioequivalence study of two flavoxate formulations involving 24 healthy volunteers. (C) 2020 Elsevier B.V. All rights reserved.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据