注射用曲克芦丁有效成分含量测定方法研究

摘要

采用高效液相色谱法,建立药品生产企业检测中心快速、有效测定曲克芦丁注射液有效成分曲克芦丁含量的方法。条件为色谱柱： Zorbax Eclipse XDB-C18250 mm×4.6 mm,5μm Column (P/N 993967-902/5063-6600)填料色谱柱；柱温：室温；流动相：磷酸盐缓冲液：乙腈=80：20为流动相；流速：1 mL/min；检测波长：252 nm。该方法样品前处理简单、精密度高、准确可靠。能够满足药品生产企业对曲克芦丁含量检测要求,操作简捷易行,适合于曲克芦丁注射液的质量控制。%The effective rapid measurement method to detect the Troxerutin active ingredient in injection Troxerutin was established based on High Performance Liquid Chromatography ( HPLC) . The method can be used in Laboratory Centre of the pharmaceutical production enterprises. The optimum conditions were as follows:Zorbax Eclipse XDB-C18 250 ×4. 6 mm, 5 μm Column ( P/N 993967-902/5063-6600 ) packing column was used at room temperature, and phosphate buffer:acetonitrile=80:20 was applied as mobile phase in flow rate of 1 mL/min, and 252 nm detection wavelength were chosen by experiment. It provided a new, convenient, rapid, accurate and reliable method for the detection of Troxerutin active ingredient in injection Troxerutin. The method can be used on troxerutin quality control in the drug manufacturer.