Concentration Determination of Inorelbine Bitartrate in Human Plasma by LC-MS/MS
10.6039/j.issn.1001-0408.2015.20.13
- VernacularTitle:LC-MS/MS法测定人血浆中重酒石酸长春瑞滨的浓度及其药动学研究
- Author:
Pei LIU
;
Lei LIU
;
Zhihao LIU
;
Changyuan WANG
- Publication Type:Journal Article
- Keywords:
Vinorelbine;
LC-MS/MS;
Pharmacokinetics;
Blood concentration
- From:
China Pharmacy
2015;(20):2774-2776,2777
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish a method for determining the concentration of vinorelbine bitartrate in human plasma, and study the pharmacokinetic process of vinorelbine in human plasma. METHODS:The samples were extracted with Solid-phase extraction(SPE). LC-MS/MS was performed on the column of Agilent Extend C18 with the mobile phase of 5 mmol/L ammonium ac-etate solution(pH10.5)-acetonitrile-methano1(18∶10∶72,V/V/V)at the flow rate of 0.4 ml/min,the ion source was ESI and MRM mode was used to scan positive ion detection. The ion reaction of quantitative analysis was m/z 779.50→m/z 122.10 (vinorelbine) and m/z 811.60→m/z 224.50 (internal standard, vinblastine). 3p97 was used to calculate the pharmacokinetic parameters. RE-SULTS:The determination was not interfered by endogenous impurities,and there was no matrix effect;the lowest limit of quantita-tive analysis was 2.0 ng/ml with the linear range of 2.0-4 000.0 ng/ml(r=0.997 8);the linear range of vinorelbine in plasma was. The intra-day and inter-day precisions and accuracy results were all in line with the acceptable limit across all concentrations. t1/2γ of 30 mg/m2,40 mg/m2 Vinorelbine Emulsion for Injection groups and 30 mg/m2 Vinorelbine for Injection group were(37.958 ± 34.256)、(47.835±54.231)、(76.873±40.537)h respectively,cmax were(1 426.250±397.562)、(1 700.125±624.669)、(2 187.500± 828.040)ng/ml respectively,AUC0-48 h were(75 839±19 551)、(82 088±14 207)、(95 318±18 208)mg·h/L respectively. CONCLU-SIONS:The method is rapid,sensitive and specific,and suitable for the determination of vinorelbine and pharmacokinetic study. Metabolic processes of vinorelbine can be described as first order process of three-compartment model in cancer patients.
