Establishment and performance evaluation of a wide-range high performance liquid chromatography method for determination of iohexol quantification / 中华检验医学杂志

ABSTRACT

Objective:To establish a method for iohexolquantification based on high performance liquid chromatography (HPLC) to measure the concentration of blood iohexolafterlow dose and contrast dose injection.Methods:Weperformed the method establishment and evaluation in this study. A HPLC-UV system (high performance liquid chromatography plus ultraviolet detector) was used to establish the method. The linearity, imprecision, recovery rate, limit of detection, lower limit of measuring interval and carryover of the method were evaluated. The stability of iohexol under different storage conditions, the differences of iohexolbetween serum and plasma concentrations, and the drug′s interference with the method were evaluated preliminarily. The single sample t test was used for the stability test of iohexolin samples, and the Wilcoxon symbol rank sum test was used for the comparison of iohexol concentrations between serum and plasma.Results:The linearity of iohexol ranging from 5 to 250 μg/ml ( R2=0.999 9) and from 250 to 4 000 μg/ml ( R2=0.999 8); when the concentration of iohexol was 20-3 000 μg/ml, the intra-and inter-assay coefficient of variation were 1.63% to 3.31% and 2.10% to 4.09%, respectively. The recovery rate was 94.17% to 106.13%; the limit of detection was 1 μg/ml and the lower limit of measuring interval was 5 μg/ml; it shows no carryover at the concentration of iohexol 4 000 μg/ml; after 48 hours at room temperature storage, the relative deviation of the concentration was -5.55% to +5.58%, after repeated freeze-thaw cycles 6 times at -80 ℃, the relative deviation of the concentration was -1.28% to+6.68%; there was no statistic difference between the measurement results between serum and plasma; valsartan and other drugs did not interfere with this methodsignificantly. Conclusion:Awide-range HPLC method for iohexolquantification has been established, which can stably and accurately detect the blood concentration of iohexol at low and contrast doses.