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Arzneimittelforschung 2011; 61(5): 287-295
DOI: 10.1055/s-0031-1296201
Antiallergic Drugs · Antiasthmatics · Antitussives · Bronchodilators · Bronchosecretogogues · Mucolytics
Editio Cantor Verlag Aulendorf (Germany)

Determination of cetirizine in human plasma using high performance liquid chromatography coupled with tandem mass spectrometric detection: application to a bioequivalence study

Xiao-Lei Ren
1   Key Laboratory of Drug Quality Control and Pharmacovigilance (China Pharmaceutical University), Ministry of Education, Nanjing, P. R. China
2   Center for Instrumental Analysis, China Pharmaceutical University, Nanjing, P. R. China
,
Yuan Tian
1   Key Laboratory of Drug Quality Control and Pharmacovigilance (China Pharmaceutical University), Ministry of Education, Nanjing, P. R. China
2   Center for Instrumental Analysis, China Pharmaceutical University, Nanjing, P. R. China
,
Zun-Jian Zhang
1   Key Laboratory of Drug Quality Control and Pharmacovigilance (China Pharmaceutical University), Ministry of Education, Nanjing, P. R. China
2   Center for Instrumental Analysis, China Pharmaceutical University, Nanjing, P. R. China
,
Yun Chen
3   Institute of Dermatology, Chinese Academy of Medical Sciences & Perking Union Medical Sciences &Perking Union Medical College, Nanjing, P. R. China
,
Li-Li Wu
3   Institute of Dermatology, Chinese Academy of Medical Sciences & Perking Union Medical Sciences &Perking Union Medical College, Nanjing, P. R. China
,
Jun Huang
1   Key Laboratory of Drug Quality Control and Pharmacovigilance (China Pharmaceutical University), Ministry of Education, Nanjing, P. R. China
2   Center for Instrumental Analysis, China Pharmaceutical University, Nanjing, P. R. China
› Author Affiliations
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Publication History

Publication Date:
27 November 2011 (online)

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Abstract

A rapid, sensitive and selective HPLC–MS/MS method was developed and validated for the quantification of cetirizine dihy-drochloride (CAS 83881-51-0) in human plasma using mosapride citrate as internal standard (IS, CAS 112885-42-4). Following liquid–liquid extraction, the ana-lytes were separated using a mobile phase consisting of methanol and aqueous ammonium acetate solution (10 mM) (60 : 40, v/v) on a reverse phase C18 column and analyzed by a triple-quadrupole mass spectrometer in the selected reaction monitoring (SRM) mode using the respective [M+H]+ ions, m/z 398 → 201 for cetirizine and m/z 422 → 198 for mosapride. The analysis time for each run was 8.0 min. The assay exhibited a linear dynamic range of 0.5–500 ng/ml for cetirizine dihydrochloride in human plasma. The lower limit of quantification (LLOQ) was 0.5 ng/ml with a relative standard deviation of less than 15% (all the concentration data in this study related to the salt (cetirizine dihydrochloride)). Acceptable precision and accuracy were obtained for concentrations over the standard curve range. It is the first time that the validated HPLC–MS/MS method has been successfully applied to a bioequivalence study in 20 healthy male Chinese volunteers.

Key words

Bioequivalence - Cetirizine dihydrochloride - HPLC-MS/MS - Human plasma
 

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