文档介绍：高效液相色谱法测定维生素K1冻干乳中药物含量
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【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( mm×250 mm,5 μm),以甲醇∶无水乙醇(70∶30)为流动相,检测波长为254 nm, mL/min,进样量20 μL,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,%,%。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。
【关键词】高效液相色谱法;维生素K1;冻干乳;含量测定
[Abstract] Objective:To determine the content of Vitamin K1 in lyophilized emulsion by reversedphase high performance liquid :The reconstituted Vitamin K1 emulsion was mixed with isopropyl alcohol. A Hypersil BDS C18 column ( mm×250 mm, 5 μm) was used. The mobile phase was methanol
dehydrated alcohol (70∶30), the UV detector at wavelength 254 nm and the flow rate mL/min. The injection volume was 20 μL and the column 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 % and RSD was %. 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.
[Key words] HPLC; Vitamin K1; Lyophilized emulsion; Determination
维生素K1为人体肝内合成凝血酶原的必需物质,可促进凝血酶原(Ⅱ因子)及其它凝血因子(Ⅷ因子、Ⅸ因子和Ⅹ因子