RP-HPLC法测定母乳中克林霉素的浓度

Determination of Clindamycin in Woman Milk by RP-HPLC

目的:建立以反相高效液相色谱法测定母乳中克林霉素浓度的方法。方法:采用液-液萃取高效液相色谱法,以替硝唑为内标进行测定,色谱柱为LunaC18,流动相为乙腈:四氢呋喃:磷酸盐缓冲液(pH5)=30:1:70,柱温为40℃,流速为0.8mL.min-1,检测波长为205nm。结果:克林霉素乳汁浓度在0.529～10.580μg.mL-1范围内线性关系良好(r=0.9967),最低检测限为0.2μg.mL-1;平均方法回收率为98.84%,低、中、高浓度的日内、日间RSD均<5%。结论:本方法简便、快速、灵敏、准确,重现性好,可用于克林霉素在母乳中的药物浓度测定。

OBJECTIVE： To determine the concentration of clindamycin in woman milk by RP -HPLC. METHODS： The concentration of clindamycin（with tinidazole served as internal standard） was determined by liquid- liquid extraction-HPLC. The chromatographic column was Luna C18 and the mobile phase consisted of acetonitrile- tetrahydrofuran- phosphate buffer （pH 5） （30 ： 1 ： 70） at a flow rate of 0.8 mL ·min -1. The temperature of the column was kept at 40 ℃ and the detection wavelength was set at 205 nm. RESULTS： The linear range of clindamycin was 0. 529~ 10. 580μg·mL-1（ r = 0.996 7） with a lowest detectable limit of 0.2μg·mL-1. The average methodological recovery rate of clindamycin was 98.84% ; both the inter- day RSD and intra- day RSD of clindamycin（at low, medium and high concentrations） were all less than 5%. CON- CLUSION： The method is simple, rapid, sensitive, accurate and reproducible, and it is applicable for the determination of clindamycin concentration in woman milk.