Lodén Henrik, Amini Ahmad
Uppsala University, Division of Analytical Pharmaceutical Chemistry, Biomedical Centre, Uppsala, Sweden.
Electrophoresis. 2007 May;28(10):1548-56. doi: 10.1002/elps.200600636.
An efficient and rapid separation method based on reversed-polarity multiple-injection CZE (MICZE), has been developed for the quantification of buserelin in a pharmaceutical product. The determinations were performed by serially injecting five standard solutions of buserelin (50-300 microg/mL) and one reference analyte into a Polybrene-coated capillary. All the samples contained goserelin, an analog peptide to buserelin, as internal standard (IS). Immediately after pressure injection, the applied sample plugs were subjected to electrophoresis for 2 min at -25 kV. Consequently, each sample plug became isolated from its neighboring plugs by the BGE, composed of 100 mM phosphate-triethanolamine buffer at pH 3.0 containing 10% v/v ACN. During separation the individual sample components migrated at similar velocities and as distinct zones through the capillary giving 24 peaks, 12 from the analyte and the IS and 12 from the sample matrix. The buserelin content of the pharmaceutical product was determined to be 0.94 +/- 0.05 mg/mL, which is only a slight deviation from the declared concentration (1 mg/mL).
已开发出一种基于反相多次进样毛细管区带电泳（MICZE）的高效快速分离方法，用于定量药品中的布舍瑞林。通过将五种布舍瑞林标准溶液（50 - 300μg/mL）和一种参比分析物依次注入涂有聚凝胺的毛细管中进行测定。所有样品均含有戈舍瑞林，一种与布舍瑞林类似的肽，作为内标（IS）。压力进样后，立即在-25 kV下对注入的样品塞进行2分钟的电泳。因此，每个样品塞通过由pH 3.0的100 mM磷酸盐 - 三乙醇胺缓冲液组成的BGE与相邻的样品塞分离，该缓冲液含有10% v/v的乙腈。在分离过程中，各个样品组分以相似的速度迁移，作为不同的区带通过毛细管，产生24个峰，12个来自分析物和内标，12个来自样品基质。该药品中布舍瑞林的含量测定为0.94±0.05 mg/mL，与申报浓度（1 mg/mL）仅略有偏差。
