多西他赛体外HPLC检测方法的建立  

A Methodology on HPLC for in Vitro Detection of Docetaxel

作　　者：邵泽洋 赵灏明 钟曼琳 陈钰滢 陈嘉瑜 李志勇 吴丽艳 Shao Zeyang;Zhao Haoming;Zhong Manlin;Chen Yuying;Chen Jiayu;Li Zhiyong;Wu Liyan(School of Pharmacy and Food Science,Zhuhai College of Science and Technology,Zhuhai 519041,China)

机构地区：[1]珠海科技学院药学与食品科学学院,广东珠海519041

出　　处：《广东化工》2022年第5期146-149,172,共5页Guangdong Chemical Industry

基　　金：2020年广东省科技创新战略专项资金项目(攀登计划专项)。

摘　　要：目的:本实验旨在建立一种多西他赛的体外含量测定方法。方法:通过对多西他赛最大吸收波长进行检测,液相色谱实验条件进行筛选;组织系统适应性实验与方法专属性实验,线性关系,精密度、溶液稳定性和加样回收率等实验,建立了多西他赛体外含量测定方法。结果:以乙腈︰水(65︰35)溶液为流动相,230nm为检测波长,在上述色谱条件下多西他赛浓度在10~70μg/mL之间线性关系良好,标准曲线为y=43.071x+12.571(r;=0.9995),加样回收率为101.8%,RSD%为1.05%,10h内多西他赛溶液室温稳定性RSD值为0.47%。结论:本实验所建立的高效液相色谱法精密度高、重现性好、稳定性及回收率都达到了药物分析的要求,可用于多西他赛的体外含量检测。Objective: To establish a methodology on HPLC for In Vitro Detection of docetaxel. Method: Investigations of the max absorption wavelength,proper chromatographic condition, system adaptability and method specificity, as well as the experiences of standard curve, sample precision, solution stability,recovery rate and other aspects are fully arranged. Results: All sample injection should be under the 230 nm and dissolved in Acetonitrile-Water solution within the VOF of 65 %, as mobile phase, following the standard curve as y=43.071 x+12.571(r;=0.9995), the sample recovery of 101.8 %, within the RSD% 1.05 %, and the 10 h stability of 0.47 %. Conclusion: It is a qualified methodology for In Vitro detection of docetaxel, regarding the qualified precision, reproducibility, stability and recovery rate for pharmaceutical analysisi purpose.

关 键 词：多西他赛 高效液相色谱法 方法学考察 含量测定 体外检测 加样回收率 

分 类 号：TQ[化学工程]