HPLC法测定注射用奈达铂中水解杂质乙醇酸的含量

HPLC determination of content of hydrolysis impurity glycolic acid in nedaplatin for injection

目的建立一种注射用奈达铂中水解杂质乙醇酸测定的HPLC方法。方法采用Shimpack VP-ODS C18（250 mm×4.6 mm,5μm）为色谱柱,以磷酸盐缓冲液（p H6.0）-乙腈（80：20）为流动相;流速为1.0m L/min;柱温：25℃;检测波长为205 nm。结果本法线性范围为0.9822～19.64μg/m L（r=0.9995）,精密度RSD为4.5%（n=5）,重复性RSD为4.0%（n=6）,回收率为94.67%～105.7%,RSD为3.2%（n=9）。结论本方法准确、专属、耐用,可以很好的控制水解杂质乙醇酸的含量。

Objective To develop a new HPLC method for the determination of hydrolysis impurity glycolic acid in nedaplatin for injection. Methods The chromatographic analysis was performed on Shimpack VP-ODS C18 （250 minx 4.6 mm, 5 μm） column, with phosphate buffer （pH 6.0）-acetonitrile （80：20） as mobile phase. The flow rate was 1.0 mL/min; the column temperature was 25 ℃, and the wavelength was set at 205 nm. Results The liner range was 0.982 2- 19.64 μg/ml （r=0.999 5）; the RSD of precision was 4.5% （n=5）; the RSD of repeatability was 4.0% （n=6）; the recovery was 94.67%-105.7%, the RSD was 3.2% （n=9）. Conclusion This method is accurate, specific and durable and it could control the content of hydrolysis impurity glycolic acid.