高效液相色谱法测定长循环自体红细胞载体中克林霉素磷酸酯和克林霉素的含量  

Determination of Clindamycin Phosphate and Clindamycin in Long-Circulating Autologous Erythrocyte-Based Drug by HPLC

作　　者：梁萌 王玉丽 杨阳 高春生 LIANG Meng;WANG Yu-li;YANG Yang;GAO Chun-sheng(Institute of Pharmacology and Toxicology,Academy of Military Medical Sciences,Academy of Military Sciences,Beijing 100850,China)

机构地区：[1]军事科学院军事医学研究院毒物药物研究所,北京100850

出　　处：《中国药学杂志》2020年第10期838-842,共5页Chinese Pharmaceutical Journal

基　　金：国家“重大新药创制”科技重大专项项目资助(2018ZX09711003-008)。

摘　　要：目的建立自体红细胞载体中包载的克林霉素磷酸酯和转化产生的克林霉素含量测定方法。方法采用高效液相色谱法,色谱柱为Shimadzu Shim-pack VP-ODS色谱柱(4.6 mm×250 mm,5μm),Waters Symmetry C18预柱(3.9 mm×22 mm,5μm),内标为尼泊金甲酯,流动相为0.0625 mol·L^-1KH2PO4-乙腈(65∶35,V/V),流速为1.0 mL·min^-1,柱温为25℃,检测波长为210 nm。结果克林霉素磷酸酯在0.253~506μg·mL^-1内质量浓度与峰面积比值呈良好的线性关系,克林霉素在0.251~502μg·mL^-1内质量浓度与峰面积比值呈良好的线性关系,方法回收率大于98%,供试溶液在4℃和室温下放置24 h均稳定,精密度符合要求。结论该方法快速、简便、准确、重复性好,可用于自体红细胞载体中克林霉素磷酸酯和转化产生的克林霉素含量的测定。OBJECTIVE To establish a high performance liquid chromatography(HPLC)method to determine the contents of clindamycin phosphate and clindamycin in long-circulating autologous erythrocyte-based drug.METHODS Clindamycin phosphate and clindamycin were determined by HPLC with Shimadzu Shim-pack VP-ODS chromatographic column(4.6 mm×250 mm,5μm)and Waters Symmetry C18 precolumn(3.9 mm×22 mm,5μm).The internal standard was nipagin ester.The mobile phase was composed of 0.0625 mol·L^-1 KH2PO4 and acetonitrile at 65∶35(V/V)at a flow rate of 1.0 mL·min^-1.The column temperature was maintained at 25℃and the detection wavelength was set at 210 nm.RESULTS The calibration curve of clindamycin phosphate showed good linearity in the range of 0.253-506μg·mL^-1,and the calibration curve of clindamycin showed good linearity in the range of 0.251-502μg·mL^-1.The average recovery was more than 98%.The test solution was stable at 4℃and room temperature for 24 h,and the precision met requirements.CONCLUSION The method is simple,specific,accurate and stable,which is suitable for the determination of clindamycin phosphate and clindamycin in long-circulating autologous erythrocyte-based drug.

关 键 词：载体药物 红细胞 克林霉素磷酸酯 克林霉素 高效液相色谱法 

分 类 号：R17[医药卫生—妇幼卫生保健]