高效液相色谱法测定肾上腺素的光学纯度

Determination of Enantiomeric Purity for Epinephrine by High Performance Liquid Chromatography

用2，6-二甲基-β-环糊精作手性流动相添加剂，C18柱为固定相，建立了D，L-肾上腺素拆分的定量分析方法。用归一化法分析D，L-异构体时引入了定量校正因子。比较了外标法和内标法定量测定L-肾上腺素的回归方程、精密度及回收率。测定了不同储存期的L-肾上腺素滴眼剂中D型异构体的质量分数。

A procedure for the resolution of D,L-epinephrine and the determination of D-isomer ratio in a pharmaceutical formulation is described. The optical isomers of epinephrine were resolved by RP-HPLC with heptakis(2,6-di-O-methyl-β-cyclodextrin)as a chiral mobile phase additives. The results showed that a correction factor must be introduced into the equation used for the calculation of the percentage of D-epinephrine, because the UV absorbance may not be the same when DM-β-CD is present. Quantitation was achieved with external and internal standard method, HVA as an internal standard. This method can be used for the determination of the D-isomer in the L-epinephrine pharmaceutical formulation. The results showed that the mass fraction of D-isomer in the formulation increased during the period of storage.