Determination the concentration of antofloxacin in human plasma by LC-MS /MS and its application in the pharmacokinetic study of antofloxacin hydrochloride
10.13699/j.cnki.1001-6821.2018.07.038
- VernacularTitle:LC-MS/MS法测定人血浆中安妥沙星的浓度及盐酸安妥沙星片在健康人体的药代动力学研究
- Author:
Hui-Juan LI
1
;
Lu-Ning SUN
;
Hong-Wen ZHANG
;
Yu-Wen YING
;
Hui-Wen JIAO
;
Yun-Su MA
;
Li-Jun XIE
;
Juan CHEN
;
Ning OU
Author Information
1. 南京医科大学第一附属医院临床药理研究室
- Keywords:
antofloxacin;
LC-MS/MS method;
pharmacokinetics
- From:
The Chinese Journal of Clinical Pharmacology
2018;34(7):866-869
- CountryChina
- Language:Chinese
-
Abstract:
Objective To develop a LC-MS/MS method for the determination of antofloxacin in human plasma and to study the pharmacokinetic characteristics of antofloxacin after oral administration of antofloxacin hydrochloride tablets.Methods The samples were precipitated by acetonitrile and ornidazole was selected as the internal standard.The separation was carried on a Agilent Poroshell 120 SB-C18(2.1 mm × 50 mm,2.7 μm) column with a mobile phase of acetonitrile:5 mmol · L-1 ammonium formate (containing 0.1% formic acid) =12∶88 at a flow of 0.4 mL · min-1 12 healthy subjects were given orally single dose of antofloxacin hydrochloride 400 mg dose,blood samples were collected at different time points,the concentration of antofloxacin in human plasma was measured,and the main pharmacokinetic parameters were calculated by DAS 2.1.1 and Excel 2003.Results All the analytes showed good linearity over their concentration ranges on 0.01-15.00 μg · mL-1 The accuracy,inter-run and intra-run precisions were all below 15%.Analytes were stable during the study.The main pharmacokinetic parameters after antofloxacin 400 mg single drug administration:Cmax was (3.57 ±0.54) μg · mL-1,tmaxwas (2.25 ±0.92) h,t1/2 was (11.76 ± 1.64) h,AUC0-1 was (60.38 ± 7.47)μg · mL-1 · h.Conclusion This method can be used to determine the concentration of antofloxacin in human plasma and to study the pharmacokinetics of antofloxacin hydrochloride tablets.