高效液相色谱法测定奥沙利铂相关杂质左旋异构体含量

Content Determination of Related Impurity L- isomer in Oxaliplatin by HPLC

目的 建立以高效液相色谱法测定奥沙利铂的相关杂质左旋异构体.方法 采用Chiralcel-OC-H手性色谱柱,以甲醇-乙醇（70：30）为流动相,流速为0.3 mL/min,柱温为40 ℃,检测波长为254 nm,进样量为20 μL.结果 奥沙利铂左旋异构体质量浓度在0.24 ～0.72μg/mL范围内与峰面积呈良好线性关系（r=0.999 2）,平均回收率为94.47％,RSD为2.75％（n=9）;奥沙利铂峰和左旋异构体（杂质D）峰的分离度、理论板数及检出灵敏度均达到要求.结论 该方法准确、简便、快速,可用于检测注射用奥沙利铂左旋异构体的含量.

Objective To establish a normal phase high performance liquid chromatography（HPLC） method to determine the related impurity L-isomer of oxaliplatin.Methods The Chiralcel-OC-H chirality chromatographic column was adopted with the mobile phase of methanol-ethanol（70：30）.The fluid velocity was 0.3 mL/min,the column temperature was 40℃,the detection wavelength was 254 nm and the sample size was 20 μL.Results The mass concentration of oxaliplatin L-isomer within the range of 0.240.72 μg/mL showed good linear relation with the peak area（r =0.9992）.The average recovery rate was 94.47%,RSD=2.75% （n=9）.The separation degree of oxaliplatin and its L-isomer（impurity D） peaks,the number of theoretical plates and the detection sensitivity all met the requirement.Conclusion This method is accurate,simple and rapid,which can be used determine the L-isomer content of Oxaliplatin for Injection.