Method development, validation and bioequivalence of varenicline in human plasma by liquid chromatography tandem mass spectrometry

被引：7

作者：

Al-Haj, Ayoub ^{[1
]}

Alawi, Mahmoud ^{[1
]}

Arafat, Tawfiq ^{[2
]}

Hourani, Mohammad Khair ^{[1
]}

机构：

[1] Univ Jordan, Dept Chem, Amman 11942, Jordan

[2] Univ Petra, Fac Pharm, Amman, Jordan

来源：

JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES | 2013年 / 931卷

关键词：

Varenicline; LC-MS/MS; Champix; Clinical study; Human plasma; RECEPTOR PARTIAL AGONIST; DOSE PHARMACOKINETICS; HEALTHY SMOKERS;

D O I：

10.1016/j.jchromb.2013.05.019

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

A method based on liquid chromatography coupled to tandem mass spectrometry was developed for quantitative determination of varenicline in human plasma. Varenicline and the internal standard (25.0 ng/mL of Clarithromycin) were extracted from human plasma by liquid-liquid extraction, using methyl tertiary butyl ether as the organic solvent. The chromatographic separation was achieved using C8 column with isocratic elution using a mixture of acetonitrile:0.001 M ammonium acetate (adjusted to pH 4.0) (70:30%, v/v). The method was validated over the concentration range of 0.1-10.0 ng/mL by investigating specificity, sensitivity, linearity, precision, accuracy, recovery, matrix effect and stability according to United State Food and Drug Administration guideline. The validated bioanalytical method was successfully applied to evaluate bioequivalence of two commercial products of 1 mg varenicline single dose. (C) 2013 Elsevier B.V. All rights reserved.

引用

页码：134 / 139

页数：6

共 15 条

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