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紫杉醇和顺铂血药浓度监测方法的建立

Establishment of Blood Drug Concentration Monitoring Method of Paclitaxel and Cisplatin

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【作者】 徐欣然; 王儒雅; 刘思雨; 耿志鹏; 赵双运; 祁欣欣; 孙雨璇; 陈纭;

【Author】 XU Xinran;WANG Ruya;LIU Siyu;GENG Zhipeng;ZHAO Shuangyun;QI Xinxin;SUN Yuxuan;CHEN Yun;School of Pharmacy Anhui Medical University;Inflammation and Immune Mediated Diseases Laboratory of Anhui Province;

【通讯作者】 陈纭;

【机构】 安徽医科大学药学科学学院; 炎症免疫性疾病安徽省实验室;

【摘要】 目的 建立同时测定紫杉醇(PTX)和顺铂(DDP)血药浓度的高效液相色谱(HPLC)法。方法 色谱柱为ODS-B C18柱(250 mm×4.6 mm,5??m),流动相为甲醇-水(70∶30,V/V ),流速为1.0 mL/min,柱温为30℃,进样量为10??L,检测波长228 nm(PTX)和254 nm(DDP)。结果 PTX和DDP衍生物[Pt-二乙基二硫代氨基甲酸钠(DDTC)2]的保留时间分别为8.84 min和12.5 min;质量浓度分别在1.0~5.0??g/mL和2.0~16.0??g/mL范围内与峰面积线性关系良好;日内和日间精密度的RSD均<10%;稳定性试验结果显示室温避光条件下质量浓度波动范围为10%~12%;冷冻条件下质量浓度波动范围为2%~4%;回收率分别为98.6%~99.4%,97.6%~98.4%(RSD均<3%)。结论 所建方法简便、准确、灵敏,结果可靠,可用于人血浆中PTX和DDP血药浓度的监测。

【Abstract】 Objective To establish a high-performance liquid chromatography(HPLC) method for the simultaneous determination of paclitaxel(PTX) and cisplatin(DDP) blood drug concentrations.Methods The chromatographic column was an ODS-B C18column(250 mm × 4. 6 mm,5 ??m),the mobile phase was methanol-water(70∶30,V/V),the flow rate was 1. 0 mL/min,the column temperature was 30 ℃,the injection volume was 10 ??L,and the detection wavelengths were 228 nm(PTX) and 254 nm(DDP).Results The retention times of PTX and DDP derivative [Pt-diethyldithiocarbamate(DDTC)2] were 8. 84 min and12. 5 min,respectively;the linear ranges were 1. 0-5. 0 ??g/mL and 2. 0-16. 0 ??g/mL,respectively;the RSDs of intra-day and inter-day precision were both lower than 10%;the stability test results showed that under room temperature and lightprotected conditions,the mass concentration fluctuation range was 10%-12%;under frozen conditions,the mass concentration fluctuation range was 2%-4%;the recoveries were 98. 6%-99. 4% and 97. 6%-98. 4%,respectively(RSDs lower than 3%).Conclusion The established method is simple,accurate,sensitive,and reliable,which can be used for monitoring the blood drug concentrations of PTX and DDP in human plasma.

【关键词】 紫杉醇; 顺铂; 高效液相色谱法; 血药浓度;
【Key words】 paclitaxel; cisplatin; HPLC; blood drug concentration;
【基金】 安徽医科大学药学创新基金科研项目[YXCX202201]
  • 【文献出处】 中国药业 ,China Pharmaceuticals , 编辑部邮箱 ,2026年10期
  • 【分类号】R969
  • 【下载频次】18
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