Pharmacokinetic study of clarithromycin in human breast milk by UPLC-MS/MS.

Kul A., Ozdemir M., Sağırlı A. O.

Journal of pharmaceutical and biomedical analysis, vol.208, pp.114438, 2021 (SCI-Expanded) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 208
  • Publication Date: 2021
  • Doi Number: 10.1016/j.jpba.2021.114438
  • Journal Name: Journal of pharmaceutical and biomedical analysis
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, Analytical Abstracts, Aquatic Science & Fisheries Abstracts (ASFA), BIOSIS, Biotechnology Research Abstracts, CAB Abstracts, Chemical Abstracts Core, Chimica, EMBASE, International Pharmaceutical Abstracts, MEDLINE, Veterinary Science Database
  • Page Numbers: pp.114438
  • Keywords: Pharmacokinetic study, Clarithromycin, Human breast milk, UPLC-MS/MS, PERFORMANCE LIQUID-CHROMATOGRAPHY, HUMAN PLASMA, ELECTROCHEMICAL DETECTION, GASTRIC-JUICE, RAT PLASMA, STABILITY, ROXITHROMYCIN, HPLC, ERYTHROMYCIN, AZITHROMYCIN
  • Istanbul University Affiliated: Yes

Abstract

This study aimed to develop a validated UPLC-MS/MS method for pharmacokinetic analysis of clarithromycin in human breast milk. For sample preparation, proteins precipitated with methanol and azithromycin were used as internal standards. Clarithromycin and azithromycin detection was achieved using electrospray ionization in positive mode. The chromatographic separation time was 5 min. The lower limit of quantification was 50 ng/mL. The calibration curve of clarithromycin was 50-4000 ng/mL, with a correlation coefficient > 0.99. The method was successfully applied to determine clarithromycin levels in breast milk obtained from a lactating mother after oral administration of a single tablet containing 500 mg of clarithromycin. The maximum human breast milk concentration (C-max) was 3660 ng/mL, the time to reach the maximum concentration (t(max)) was 2.5 h, and the area under curve (AUC(0-24)) was 18450 ng h/mL. The present study provides a novel UPLC-MS/MS method for pharmacokinetic analysis of clarithromycin in breast milk. (C) 2021 Elsevier B.V. All rights reserved.