高效液相色谱手性流动相法测定盐酸肾上腺素注射液中S-对映体含量  

Determination of S-isomer in Epinephrine Hydrochloride Injection by HPLC with Chiral Mobile Phase Additives

作　　者：金丽[1] 周建丽[1] 张晓丹[1] 古卓良[1] 卜莹[1] 

机构地区：[1]南京军区联勤部药品仪器检验所,南京210002

出　　处：《医药导报》2015年第6期799-801,共3页Herald of Medicine

摘　　要：目的：建立肾上腺素光学异构体中 S-对映体的高效液相色谱手性流动相检测方法。方法 Purospher STAR RP-18色谱柱（4.6 mmx250 mm,5μm）,流动相：10 mmol·L-1磷酸二氢钠缓冲液（含10 mmol·L-1手性添加剂磺丁基-b-环糊精,磷酸调节 pH 至3.0）-乙腈（98.5：1.5）,流速0.8 mL·min-1,柱温30℃,检测波长280 nm。结果肾上腺素 S-对映体在浓度5.02-501.50μg · mL-1范围内与峰面积呈良好的线性关系,相关系数0.9997,检测限0-05μg·mL-1。结论该方法重复性、耐用性好,适用于盐酸肾上腺素注射液中 S-对映体杂质含量的测定。Objective To establish a method for the chiral separation and determination of S-isomer in epinephrine hydrochloride injection by HPLC with chiral mobile phase additives. Methods Column of Purospher STAR RP-18 （4. 6 mmx250 mm, 5 μm） was used. The mobile phase was acetonitrile-10 mmol·L-1 sodium dihydrogen phosphate buffer containing 10 mmol·L-1 sulfobutylether-b-cyclodextrin （pH adjusted to 3. 0 with phosphoric acid） （98. 5：1. 5）, detection wavelength was 280 nm, the flow rate was 0. 8 mL·min-1 , and the column temperature was 30 ℃ . Results Good linear relationship was established between the peak area and the concentration of S-isomer over the range of 5. 02-1501. 50 μg·mL-1 （R2 =0. 999 7）. The detection limit was 0. 05 μg·mL-1 . Conclusion The proposed method shows high repeatability and durability. It can be employed for the quality control of S-isomer in epinephrine hydrochloride injection.

关 键 词：肾上腺素注射液 盐酸 色谱法 高效液相 手性流动相 添加剂 S-对映体 

分 类 号：R971.3[医药卫生—药品]