【摘要】 目的:建立反相高效液相色谱法测定维生素K₁冻干乳中药物含量。方法:冻干乳重建后用异丙醇破乳。采用Hypersil BDS C₁₈柱（4.6mm×250 mm,5μm）,以甲醇:无水乙醇（70:30）为流动相,检测波长为254nm,流速为1.0mL/min,进样量20μL,柱温35℃。结果:制剂中辅料对主药测定无干扰,维生素K₁在25～250 mg/L范围内峰面积与浓度线性关系良好,平均回收率为100.99%,RSD为0.24%。结论:异丙醇破乳效果良好,且对主药测定无影响。该方法简便、迅速、准确,可用于该制剂的质量控制。更多还原

【Abstract】 Objective:To determine the content of Vitamin K₁ in |yophilized emulsion by reversed-phase high performance liquid chromatography.Methods:The reconstituted Vitamin K₁ emulsion was mixed with isopropyl alcohol.A Hypersil BDS C₁₈ column （4.6 mm×250 mm,5μm） was used.The mobile phase was methanol-dehydrated alcohol （70:30）,the UV detector at wavelength 254 nm and the flow rate 1.0 mL/min.The injection volume was 20μL and the colunm temperature 35℃.Results:The excipients did not interfere with the determination of Vitamin K₁.The method proved to be linear within the range of 25～250 mg/L.The recovery of the assay was 100.99% and RSD was 0.24%.Conclusions:Isopropyl alcohol can play a good role in emulsion breaking,meanwhile have no impact on measurement of Vitamin K₁.The method appears to be simple,speedy,accurate and can be used to control the preparation quality.更多还原