盐酸肾上腺素注射液中S-对映体的测定及稳定性考察

目的:建立肾上腺素对映异构体中S-对映体的高效毛细管电泳检测方法。方法:采用未涂层熔融石英毛细管(50μm×42 cm,有效长度32 cm),以含13 mmol·L-1DM-β-CD pH 2.5的缓冲体系(含0.10 mol·L-1磷酸和0.07 mol·L-1三乙胺)为背景电解质溶液,在20 kV分离电压下,于214 nm波长处测定S-对映体。结果:肾上腺素R-对映体和S-对映体浓度分别在0.0026～0.1036 mg·mL-1范围内线性关系良好,相关系数分别为0.9995和0.9999(n=6);定量限分别为0.3和0.4μg·mL-1(S/N≥10),检测限分别为0.1μg·mL-1(S/N≥3)。结论:本方法灵敏度高,重复性好,可用于盐酸肾上腺素注射液中S-对映体的测定及稳定性研究。

Determination of S-isomer in epinephrine hydrochloride injection by capillary electrophoresis and stability evaluation

Objective:To establish a capillary electrophoresis-ultraviolet detection(CE-UV) method for the chiral separation and determination of S-isomer of epinephrine hydrochloride injections.Methods:With a 42 cm length of 50 μm i.d.fused-silica capillary,well-defined separation of R-isomer and S-isomer of epinephrine hydrochloride was achieved in the H3PO4(0.10 mol·L-1)-TEA(0.07 mol·L-1)running buffer with 13 mmol·L-1 DM-β-CD(pH 2.5) at 214 nm with the applied voltage of +20 kV.Results:Good linear relationship was established between the peak response and the concentration of 0.0026-0.1036 mg·mL-1each analyte with the quantitation limit(S/N=10) of 0.3 and 0.4 μg·mL-1,and the detection limit(S/N=3) of 0.1 μg·mL-1,respectively.Conclusion:The proposed method shows high sensitivity,repeatability and stability.It can be employed for the quality control and stability research of S-isomer of epinephrine hydrochloride injections.