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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】 paclitaxelcisplatinHPLCblood 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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