格隆溴铵立体异构体杂质的毛细管电泳测定——推荐一个药物分析实验

doi:10.3866/PKU.DXHX202307023

University Chemistry ›› 2023, Vol. 38 ›› Issue (12): 67-74.doi: 10.3866/PKU.DXHX202307023

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Determination of Stereoisomeric Impurities of Glycopyrrolate Bromide by Capillary Electrophoresis: Recommendation of a Pharmaceutical Analysis Experiment

Feng Li¹^,*(), Ranran Meng², Hanzhi Zhang³, Yingjuan Qu¹, Jingwu Kang²^,*()

¹ Xi’an Key Laboratory of Food Safety Testing and Risk Assessment, School of Chemical Engineering, Xi’an University, Xi’an 710065, China
² State Key Laboratory of Chemical Biology, Shanghai Institute of Organic Chemistry, Chinese Academy of Sciences, Shanghai 200032, China
³ Abiochem Biotechnology Co., Ltd., Shanghai 200241, China

Received:2023-07-10 Accepted:2023-11-14 Published:2023-11-21
Contact: Feng Li, Jingwu Kang E-mail:lifeng_sunny@163.com;jingwu.kang@sioc.ac.cn

Abstract

Abstract:

This article recommends a pharmaceutical analysis experiment “chiral capillary electrophoresis analysis of the stereoisomers of the drug Glycopyrrolate bromide”. The experiment includes the selection of cyclodextrin chiral selector, optimization of capillary electrophoresis separation conditions, and construction of a standard curve. From the perspective of pharmaceutical analysis, this experiment focuses on introducing the principle of capillary electrophoresis analysis, the principle of chiral separation, and the importance of analyzing stereoisomeric impurities in drugs. It is suggested to be offered in majors such as applied chemistry, pharmacy, and pharmaceutical engineering.

Key words: Capillary electrophoresis, Chiral analysis, Glycopyrrolate bromide, Cyclodextrin, Pharmaceutical analysis experiment

Feng Li, Ranran Meng, Hanzhi Zhang, Yingjuan Qu, Jingwu Kang. Determination of Stereoisomeric Impurities of Glycopyrrolate Bromide by Capillary Electrophoresis: Recommendation of a Pharmaceutical Analysis Experiment[J].University Chemistry, 2023, 38(12): 67-74.

Figures/Tables 8

References 16

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异构体名称	日内的重复性(RSD%，n = 6)		日间的重复性(RSD%，n = 6)
异构体名称	迁移时间	峰面积	迁移时间	峰面积	线性方程	R²	LOQ (mg∙mL⁻¹)	LOD (mg∙mL⁻¹)
Glycopyrrolate	0.03	7.88	1.78	8.04	y = 219680x + 33.94	0.996	0.015	0.005
Impurity A	0.05	8.23	1.60	5.28	y = 229457x − 1504	0.990	0.015	0.005
Enantiomer	0.11	10.77	1.60	0.63	y = 249739.8x − 3220	0.992	0.015	0.005
Impurity B	0.16	6.92	1.84	11.69	y = 242651x − 1513	0.996	0.015	0.005

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Determination of Stereoisomeric Impurities of Glycopyrrolate Bromide by Capillary Electrophoresis: Recommendation of a Pharmaceutical Analysis Experiment

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