高效液相色谱法测定儿童万古霉素血药浓度

Determination of vancomycin concentration in children plasma by high-performance liquid chromatography

目的:建立高效液相色谱法测定儿童万古霉素血药浓度,并为临床评估疗效、调整给药剂量提供方法学基础。方法:建立万古霉素标准曲线,血浆样品通过10%硫酸锌沉淀,采用Insertil ODS-3色谱分析柱,以甲醇、磷酸二氢钾缓冲液、乙腈(pH=3.20 10∶86∶4)(v/v/v)为流动相,流速1m L·min^(-1),检测波长为196nm,柱温为28℃,进样量为20μL。结果:万古霉素血浆样品质量浓度在1.5625mg·L^(-1)至100mg·L^(-1)范围内呈良好的线性关系(r=0.9996,n=7)。低、中、高3个质量浓度溶液的方法回收率分别为98.52%±3.88、97.52%±1.74和100.00%±4.86,RSD分别为3.94%、1.79%和4.86%。结论:本方法灵敏、快速、简便、可靠,可用于儿童万古霉素的血药浓度监测及临床药学研究。

Objective： To develop a high-performance liquid chromatographic（HPLC） method for the determination of Vancomycin concentration in children plasma and establish the foundation of the assessment about clinical therapeutic effect and the dosage adjustment.Methods： A protein precipitation technique was developed with 10% zinc sulfate. An Insertil ODS-3 column at 28 ℃ was used with an ultraviolet detector set at 196 nm. The mobile phase consisting of methanol-acn-KH2PO4 buffer solution（pH=3.20 10∶4∶86）was used at a flow rate of 1.0m L/min. The injection volume was 20μL. Results： The standard curves were liner over the ranges of 1.5625 to 100mg/L（r =0.9996,n =7）. The extraction recovery were 1.54 ±0.06,12.20 ±0.22 and 100.00 ±4.86,with RSD 3.94%,1.79 % and4.86% at the low,middle and high concentration respectively. Conclusion： The assay is sensitive,rapid,simple and reliable,and can be successfully applied to monitoring vancomycin concentrations in children plasma and clinical pharmacy research.