Uncertainty of Measurement for Cefixime in Human Plasma by HPLC-MS/MS / 医药导报

ABSTRACT

Objective To develop a method on evaluating the uncertainty during the determination of cefixime in human plasma by high performance liquid chromatography-tandem mass spectrometry ( HPLC-MS/ MS). Methods We analyzed various factors that can cause the uncertainty in the whole process of determination, which includ repeatability, weighting,preparation of standard solutions, sample preparation, equipment error and calibration curve fitting. The expanded uncertainty was evaluated by calculating uncertainty of each component and combined. Results The expanded uncertainty for low ( 80 ng ? mL-1 ), medium ( 560 ng ? mL-1 ) and high ( 9 600 ng ? mL-1 ) level of cefixime was 14. 93, 23. 65, 137.95 ng?mL-1 ,respectively (P= 95%). Conclusion The uncertainty of determining cefixime in human plasma by HPLC-MS/ MS is mainly caused by the calibration curve fitting,repeatability and HPLC-MS/ MS error.