【摘要】 目的建立测定克唑替尼含量和有关物质的HPLC法。方法采用C₁₈VP-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^-1152. 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。更多还原

【Abstract】 OBJECTIVE To establish a HPLC method for the determination of crizotinib and the related substances. METHODS The separation was performed on a C₁₈ VP-ODS（ 4. 6 × 150 mm,5μm） column. The mobile phase consisted of methanol-0. 1 mol · L^-1 Ammonium phosphate solution（ 60 ∶ 40）. The detective wavelength was268 nm. The column temperature was 30℃. The flow rate was 0. 6 mL · min^-1. The injection volume was20μL. RESULTS This method can separate crizotinib and the related substances. 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.更多还原