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目的采用HPLC法测定抗癌新药硼替佐米原料药中的光学异构体(1R,2R)。方法色谱柱为Chiralpak AD-H手性柱,流动相为正己烷-乙醇(90∶10),柱温30℃,检测波长270 nm,流速0.6 mL·min-1,进样量20μL。结果能较好地分离硼替佐米与光学异构体(1R,2R),分离度为7.8;异构体(1R,2R)0.75~7μg·mL-1与峰面积的线性关系良好(r=0.9993);平均回收率为98.9%,RSD=0.5%(n=9)。结论所用方法操作简单,稳定性好,灵敏度高,可用于硼替佐米原料药中光学异构体(1R,2R)的测定。
OBJECTIVE To determine the optical isomers (1R, 2R) in the anticancer drug bortezomib by HPLC. Methods The chromatographic column was Chiralpak AD-H chiral column. The mobile phase was n-hexane-ethanol (90:10). The column temperature was 30 ℃, the detection wavelength was 270 nm, the flow rate was 0.6 mL · min-1 and the injection volume was 20 μL. The results showed that the separation of bortezomib and optical isomer (1R, 2R) was good and the resolution was 7.8. The linear relationship between the isomer (1R, 2R) 0.75-7μg · mL-1 and peak area was good (r = 0.9993). The average recovery was 98.9% with RSD = 0.5% (n = 9). Conclusion The method is simple, stable, and sensitive. It can be used for the determination of optical isomers (1R, 2R) in bortezomib APIs.