摘要
目的建立木糖醇注射液中有关物质的测定方法。方法采用磺化交联的苯乙烯二乙烯基苯共聚物为填充剂的强阳离子钙型交换柱,流动相为超纯水,流速为0.5m L·min-1,柱温80℃,进样量20μL,检测器采用示差检测器。结果 D-木糖在5.17μg·m L-1~206.8μg·m L-1范围内浓度与峰面积呈良好的线性关系,r=0.9998。结论该方法准确可靠,专属性强,可对于木糖醇注射液中的中间体和其他杂质进行有效检测,控制木糖醇注射液的质量。
OBJECTIVE To establish a method for determination of related substances in Xylitol Injec- tion. METHODS Using strongly crosslinked calcium ion exchange column of sulfonated crosslinked styrene two vinyl benzene copolymer as filler,mobile phase was ultra pure water, flow rate was 0. 5 mL · min- 1, column temperature was 80℃ ,the sample quantity was 20μL,and the detector used differential detector. RESULTS The concentration and peak area of the D-Xylose in the range of 5. 17μg · mL-1 to 206. 8μg · mL-1 showed a good linear relationship, r =0. 9998. CONCLUSION The method is accurate,reliable and specific. It can effectively detect the intermediates and other impurities in Xylitol Injection and control the quality of Xylitol Injection.
出处
《海峡药学》
2017年第11期77-79,共3页
Strait Pharmaceutical Journal
关键词
木糖醇注射液
有关物质
示差检测器
Xylitol Injection
Related substances
Differential detector
