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(50 μm×42 cm,有效长度32 cm),以含13 mmol·L^-1 DM-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0.4 μg·mL^-1 (S/N≥10),检测限分别为0.1 μg·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。

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.

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