title: Simultaneous determination of ambroxol and salbutamol in human plasma by ultra-performance liquid chromatography-tandem mass spectrometry and its application to a pharmacokinetic study.
abstract: A rapid, selective and sensitive liquid chromatography-tandem mass spectrometry assay method was developed for simultaneous determination of ambroxol and salbutamol in human plasma using citalopram hydrobromide as internal standard (IS). The sample was alkalinized with ammonia water (33:67, v/v) and extracted by single liquid-liquid extraction with ethyl acetate. Separation was achieved on Waters Acquity UPLC BEH C18column using a gradient program at a flow rate of 0.2 mL/min. Detection was performed using electrospray ionization in positive ion multiple reaction monitoring mode by monitoring the ion transitions m/z 378.9 → 263.6 (ambroxol), m/z 240.2 → 147.7 (salbutamol) and m/z 325.0 → 261.7 (IS). The total analytical run time was relatively short (3 min). Calibration curves were linear in the concentration range of 0.5-100.0 ng/mL for ambroxol and 0.2-20.0 ng/mL for salbutamol, with intra- and inter-run precision (relative standard deviation) <15% and accuracy (relative error) ranging from 97.7 to 112.1% for ambroxol and from 94.5 to 104.1% for salbutamol. The method was successfully applied in a clinical pharmacokinetic study of the compound ambroxol and salbutamol tablets.
authors.affiliation: Clinical Pharmacology Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou, 215006, Jiangsu, China.|Department of Pharmaceutics, College of Pharmaceutical Science, Soochow University, Suzhou, Jiangsu, China.
authors.forename: Zhening
authors.initials: Z
authors.lastname: Guo
authors.affiliation: QingDao Chiatal Haier Pharmaceutical Co.Ltd, Qingdao, Shandong, China.
authors.forename: Yangsheng
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Clinical Pharmacology Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou, 215006, Jiangsu, China.
authors.forename: Xiaoliang
authors.initials: X
authors.lastname: Ding
authors.affiliation: Clinical Pharmacology Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou, 215006, Jiangsu, China.
authors.forename: Chenrong
authors.initials: C
authors.lastname: Huang
authors.affiliation: Clinical Pharmacology Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou, 215006, Jiangsu, China. miaolysuzhou@163.com.|Department of Pharmaceutics, College of Pharmaceutical Science, Soochow University, Suzhou, Jiangsu, China. miaolysuzhou@163.com.
authors.forename: Liyan
authors.initials: L
authors.lastname: Miao
mesh_terms: D000293:Adolescent; D000328:Adult; D000420:Albuterol / Q000097:blood*; D000551:Ambroxol / Q000097:blood*; D001993:Bronchodilator Agents / Q000097:blood*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D005100:Expectorants / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D057230:Limit of Detection; D059625:Liquid-Liquid Extraction / Q000379:methods; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results; D053719:Tandem Mass Spectrometry / Q000379:methods*; D055815:Young Adult
chemical_list: D001993:Bronchodilator Agents; D005100:Expectorants; D000551:Ambroxol; D000420:Albuterol
keywords: LC-MS/MS; ambroxol; pharmacokinetics; salbutamol; simultaneous determination