Uncertainty Evaluation on Determination of Clopidogrel Active Metabolite Derivative in Human Plasma by LC-MS/MS
10.6039/j.issn.1001-0408.2015.23.13
- VernacularTitle:LC-MS/MS法测定人血浆中氯吡格雷活性代谢物衍生物浓度的不确定度评定Δ
- Author:
Shenghui MEI
;
Weixing FENG
;
Yueting ZHU
;
Li YANG
;
Ming ZHAO
;
Zhigang ZHAO
- Publication Type:Journal Article
- Keywords:
Clopidogrel active metabolite derivative;
LC-MS/MS;
Plasma;
Uncertainty
- From:
China Pharmacy
2015;(23):3206-3209
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To evaluate the uncertainty of the determination of clopidogrel active metabolite derivative(CAMD) in human plasma by LC-MS/MS. METHODS:The course of CAMD determination in human plasma by LC-MS/MS were analyzed to evaluate the uncertainty caused by evaluate repeatability,weighing,standard solution preparation,biological sample prepara-tion,recovery,instrument precision and calibration curve fitting in CAMD assay;the uncertainty were calculated and expanded. RESULTS:The expanded uncertainty for low(0.107 ng/ml),medium(4.467 ng/ml)and high(155.667 ng/ml)levels of CAMD were 0.010 2 ng/ml,0.188 ng/ml and 6.413 ng/ml,respectively(k=2,P=95%). CONCLUSIONS:The uncertainty of the CAMD determination in human plasma by LC-MS/MS at low concentration is mainly caused by calibration curve fitting;at medium and high concentrations is mainly caused by biological sample preparation,extraction procedure,standard solution preparation and in-strument precision.