The degree of substitution for sulfobutyl ether b-cyclodextrin (SBE-b-CD) has historically been characterized by nuclear magnetic resonance spectroscopy, but this approach provides gross values for the degree of substitution. The capillary electrophoresis method described here resolves the mixture of positional and regional isomers based on the degree of sulfo butyl ether substitution. Indirect UV detection has been used, where the detection of cyclodextrin is accomplished by a decrease in background absorbance of the background electrolyte buffer benzoic acid. Ten peaks of SBE-b-CD were well resolved with an optimum pH of 8.0 using an Agilent 50 μm id, 56 cm length bare fused silica capillary. The system suitability requirements were passed as per United States Pharmacopeia (USP), and acceptence criteria for averge degree of substitution 6.2 to 6.9 were met.
本实验使用擅长在中性条件下分析碱性化合物的CAPCELL PAK MGII色谱柱,按照客户指定方法对其所提供注射用泮托拉唑钠样品进行分析。首先,按照有关物质项下方法进行分析,结果如图1、2。泮托拉唑钠峰理论塔板数为173948,远超标准要求的2500;杂质A与泮托拉唑钠主峰得到良好分离,分离度为7.83。 其次,按照有关物质项下杂质D、F的色谱条件与系统适用性方法进行分析,结果如图3、4。泮托拉唑钠峰理论塔板数为18314,杂质D、F之间分离度为1.24,符合分离度不小于1.2的要求。 接下来,按照含量测定项下方法进行分析,结果如图5。泮托拉唑钠峰理论塔板数为20149,超过要求的2500。