Application of LC-MS/MS Method for the Determination of Carbamazepine in Human Plasma and Exter-nal Quality Assessment / 中国药房

ABSTRACT

OBJECTIVE:To establish and validate the method for the determination of carbamazepine (CBZ) in human plas-ma,and to apply the method for external quality assessment. METHODS:After precipitated with acetonitrile,the plasma sample was determined by LC-MS/MS. Using loratadine as internal standard,the determination was performed on Kromasil C18 column with mobile phase consisted of water (containing 0.1% formic acid)-acetonitrile (gradient elution) at flow rate of 0.6 ml/min and column temperature of 40 ℃. The ion transitions under MRM mode by ESI+ ionization were performed at m/z 237.1→194.0 and m/z 383.1→267.0 for CBZ and internal standard,respectively. RESULTS:The linear range of CBZ were 5-1 000 ng/ml (r>0.998). The limit of quantitation was 5 ng/ml. RSDs of inter-day and intra-day were 1.00%-6.42%;relative deviation were -6.93%-0.32%. The external quality assessment of 5 samples were 679.0,475.0,104.0,29.2 and 26.2 ng/ml,respectively. The pass rate of assess-ment result was 100%. CONCLUSIONS:The method is sensitive,accurate and specific. The method is applicable for the plasma concentration determination and external quality assessment of CBZ.