HPLC法测定克唑替尼的含量及有关物质

Determination of Content of Crizotinib and Related Substances by HPLC

目的建立测定克唑替尼含量和有关物质的HPLC法。方法采用C_(18)VP-ODS柱(4. 6×150mm,5μm);以甲醇:0. 1M磷酸氢二铵(60∶40)为流动相;检测波长:268nm;柱温:30℃;流速:0. 6mL·min^(-1);进样量:20μL。结果本方法能较好地分离克唑替尼及其有关物质,克唑替尼在15. 28μg·mL^(-1)~152. 80μg·mL^(-1)内呈良好的线性关系(r=0. 9995)。回收率为100. 2%(n=9,RSD=0. 82%)。结论该方法灵敏快速、结果准确、重现性好,可用于克唑替尼原料药的含量测定及有关物质检查。

OBJECTIVE To establish a HPLC method for the determination of crizotinib and the related substances. METHODS The separation was performed on a C 18 VP-ODS （4.6×150mm,5μm） column.The mobile phaseconsisted of methanol-0.1mol·L -1 Ammonium phosphate solution （60∶〗40）.The detective wavelength was 268nm.The column temperature was 30℃.The flow rate was 0.6mL·min -1 .The injection volume was 20μL. RESULTS This method can separate crizotinib and the related ubstances.A good linearity was obtained over the range of 15.28μg·mL -1 -152.80μg·mL -1（r=0.9995）.The average recovery was 100.2% （n=9,RSD=0.82%）. CONCLUSION The method is simple,quick,sensitive,accurate,repeatable and can be used to determine the content of crizotinib and the related substances.