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| Determination of R(-)- isomer in repaglinide tablets by capillary electrophoresis |
| YUAN Xiao-wei, SUN Jia-yi, WANG Shi-zhuo, GUO Xing-jie |
| School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China |
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Abstract Objective： To develop a capillary electrophoresis system for enantiomeric impurity test of repaglinide.Methods： An uncoated fused silica capillary (50 μm×50 cm, with an effective length of 41 cm) was used. The running buffer was composed of 30 mmol/L NaH2PO4 and 5 mg/ml carboxymethyl-β-cyclodextrin（pH 3.5）. Results： Linear range was 2.00-80.00 μg/ml (correlation coefficient was 0.9993). The average recovery rate was 92.5% to 105.0%. Conclusion： The method is simple, accurate and sensitive and it can be used for determination of enantiomeric impurities in repaglinide tablet.
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Received: 30 December 2013
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Corresponding Authors:
GUO Xing-jie, E-mail: syykdx410@163.com
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毛细管电泳法检查瑞格列奈片中左旋异构体杂质
目的：建立毛细管电泳法检测瑞格列奈片中左旋异构体杂质。方法：采用未涂层熔融石英毛细管柱(50 μm×50 cm，有效长度41 cm)为分离通道,运行缓冲液为pH 3.5, 30 mmol/L的磷酸二氢钠缓冲溶液，含5 mg/ml CM-β-CD。结果：左旋瑞格列奈在浓度为2.00～80.00 μg/ml范围内线性关系良好 (r=0.9993)，方法回收率为92.5%～105.0%。结论：本实验建立的方法简单、准确、灵敏，可用于瑞格列奈片中左旋异构体杂质的检测。
关键词：
氨甲酸酯类/分析,
氨甲酸酯类/类似物和衍生物,
电泳,
毛细管/方法,
立体异构现象,
瑞格列奈
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