高效液相色谱法测定注射用卡铂和奈达铂的含量

Determination of carboplatin and nedaplatin injection by HPLC

目的建立同时测定注射用卡铂和奈达铂的液相测定方法。方法采用RP-HPLC进行测定。采用Kromasil-NH2柱(4.6mm×250mm,5μm),流动相为0.01mol·L-1枸橼酸(三乙胺调节pH值至6.0)-乙腈(70∶30),检测波长为210nm,外标法。结果峰面积与浓度线性关系良好,卡铂和奈达铂的回归方程分别为:y=1E+07x+36454,r=0.9999;y=1E+07x+78792,r=0.9997。两者的回收率和RSD分别为:99.75%(n=9),0.5%;99.82%(n=9),0.47%。结论该方法操作简便、结果准确、重现性好。

OBJECTIVE To develop a method determining the contents of Carboplatin and Nedaplatin injection by HPLC. METHODS The analysis was carried out on a column of Kromasil-NH2（4. 6mm×250mm,5μm） with a mobile phase of 0.01 mol·L^-1 Citric acid monohydrate-Acetonitrile （70 ： 30） at a flow rate 1.0ml·min^-1,the determination wavelength was 210nm. RESULTS The linear regress equations of the two drug were y=1E＋07x＋36454,r=0. 9999 and y= 1E＋07x＋78792 r=0. 9997 respectively. The average recovery were 99.75% （n=9）,RSD 0. 5% and 99.82% （n=9）,RSD 0.4% respectively. CONCLUSION The method was rapid simple and accurate.