摘要
目的:手性拆分奥美拉唑对映异构体,建立检查埃索美拉唑钠原料药中R-异构体的HPLC方法。方法:采用Chiral pak IC手性柱(4.6mm×250mm,5μm),以正己烷-异丙醇-甲醇-三乙胺(40:40:20:0.1,v/v/v/v)为流动相,检测波长为302 nm,柱温为30℃,流速为1.0 mL·min^(-1)。结果:埃索美拉唑及其R-异构体的分离度(R)大于7。R-异构体的检测限和定量限分别为32ng·mL^(-1)和80ng·mL^(-1),线性范围为0.5~30μg·mL^(-1)。自制三批埃索美拉唑钠盐中R-异构体的含量均为0.02%,R-异构体的限度符合要求。结论:该方法简便,快速,可用来检查埃索美拉唑钠原料药中R-异构体的限度。
To develop an HPLC method for the chiral separation of R-isomer in esomepra-zole（the S-isomer of omeprazole）. Methods： The enantiomers were separated by HPLC on a Chiral pak IC column （4.6 mm ×250 mm, 5μm） with the mobile phase consisting of n-hexane, isopropanol, methanol, and triethylamine（40∶40∶20∶0.1, v/v/v/v） and flowing at 1.0 mL·min-1. The detection wavelength was 302 nm and the separating column temperature was 30 ℃. Results： The resolution between esomeprazole and its R-enantiomer was higher than 7 at the optimized condition, the limits of detection and quantitation of R-enantiomer were 32 ng·mL-1 and 80 ng·mL-1, respectively, and linearity over the concentration range 0.5~30μg·mL-1 for R-enantiomer was obtained. The content of R-enantiomer impurity in esomeprazole sodium was within the limits. Conclusion： The established HPLC method is simple, fast, and suitable for the detection of R-enantiomer impurity in esomeprazole.
出处
《药学与临床研究》
2014年第4期329-331,共3页
Pharmaceutical and Clinical Research
基金
药物质量与安全预警教育部重点实验室项目(MKLDP2013QN02)
中央高校基本科研业务费专项资金(JKQZ2013028)
关键词
奥美拉唑
埃索美拉唑
高效液相色谱法
手性拆分
Omeprazole
Esomeprazole
High performance liquid chromatography（HPLC）
Chiral separation
