摘要
目的:用手性固定相拆分麻黄碱对映体,并建立检测麻黄碱对映体光学纯度的高效液相色谱法。方法:采用 CHIRAL-CEL OD-H(250 mm×4.6 mm,5 μm)手性柱,柱温为22℃,以正己烷-异丙醇-二乙胺(96:4:0.2)为流动相,流速0.5 mL·min^(-1),在257 nm 检测。结果:麻黄碱对映体拆分效果好,分离度大于2.5,最低检测限分别为5 ng 和10 ng。麻黄碱浓度在0.001～0.25 mg·mL^(-1)范围内线性关系良好(r=0.9999)。结论:该方法操作简单,快速,重复性好,可有效地控制药品质量。
Objective： To establish a chiral stationary phase high performance liquid chromatographic （CSP- HPLC） method for separating the enantiomers of ephedrine and determining the content of D- ephedrine. Metbods：A CHIRALCEL OD-H （250 mm ×4. 6 mm,5 μm） column was used,the mobile phase was composed of n- hexane - isopropyl alcohol - diethylamine （ 96 ： 4： 0. 2 ）, the detection wavelength was set at 257 nm, the flow rate was 0. 5 mL ·min ^-1, the column temperature was at 22 ℃. Results：The two enantiomers could be separated wthin 25 minutes without derivatization and the resolution was above 2. 5. The detection limits were 5 ng for L - ephedrine and 10 ng for D - ephedrine. The linear carlibration curves were obtained in the concentration range of 0. 001 - 0. 25 mg · mL ^-1 （ r = 0. 9999 ）. Conclution： The presented study provides a simple and reproducible method for the enantiomic quality control of L -ephedrine.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2007年第6期854-856,共3页
Chinese Journal of Pharmaceutical Analysis
