RP-HPLC法测定小分子靶向民诺莫司汀的含量  

RP-HPLC determination of small molecular targeted antineoplastic drug minomustine

作　　者：罗英[1] 陈悦[2] 洪利娅[1,2] 葛求富[3] 

机构地区：[1]浙江工业大学化学工程与材料学院,杭州310014 [2]浙江省食品药品检验所,杭州310004 [3]杭州民生药业有限公司,杭州310011

出　　处：《药物分析杂志》2013年第4期616-619,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立RP-HPLC法测定小分子靶向抗肿瘤创新药民诺莫司汀的含量。方法:采用安捷伦Zorbax eclipse plus C18柱(250 mm×4.6 mm,5μm),流动相:0.68%磷酸二氢钾溶液(含0.1%三乙胺,用磷酸调节pH至3.1)-乙腈(75∶25);流速:1.0 mL.min-1;检测波长:231 nm;柱温:35℃。结果:主峰能与相邻杂质峰较好地分离,民诺莫司汀在0.062～0.62 mg.mL-1范围内呈良好的线性关系(r=0.9999);平均回收率为99.9%(RSD=0.58%,n=9);重复性试验测得的精密度为0.23%(n=6);检测限为0.5 ng、定量限为1.0 ng。结论:该方法灵敏、准确、专属性好,可用于民诺莫司汀原料的含量测定。Objective：To establish an RP-HPLC method for the determination of minomustine,an innovative small molecular targeted antineoplastic drug.Methods：Agilent Zorbax eclipse plus C18 column（250 mm×4.6 mm,5 μm）was adopted with the mobile phase consisting of 0.68% potassium dihydrogen phosphate（containing 0.1% triethylamine,adjust to pH 3.1 with phosphoric acid）–acetonitrile（75∶ 25）at the flow rate of 1.0 mL·min^-1;detection wavelength was at 231 nm,and the column temperature was 35 ℃.Results：The main peak was well separated from adjacent impurities and the linear range of the method was 0.062-0.62 mg·mL^-1（r=0.9999）,the average recovery was 99.9%（RSD=0.58%,n=9）,RSD of repetitive test was 0.23%（n=6）,the limit of detection and quantitation was 0.5 ng and 1.0 ng,respectively.Conclusion：The established method was sensitive,accurate and specific,which can be used for minomustine determination.

关 键 词：反相高效液相色谱法 靶向抗肿瘤创新药 抗肿瘤药 民诺莫司汀 含量测定 

分 类 号：R286.0[医药卫生—中药学]