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盐酸肾上腺素注射液中S-对映体的测定及稳定性考察 被引量:2

Determination of S-isomer in epinephrine hydrochloride injection by capillary electrophoresis and stability evaluation
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摘要 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。 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^-1D M -β- C D (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 · L^-1 leaeh 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 · 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.
出处 《药物分析杂志》 CAS CSCD 北大核心 2012年第2期273-276,共4页 Chinese Journal of Pharmaceutical Analysis
关键词 盐酸肾上腺素注射液 稳定性 高效毛细管电泳 S-对映体 epinephrine hydrochloride injection stability capillary electrophoresis S - isomer
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