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己酮可可碱为扩张血管、改善微循环的药物,其注射液并没有有关物质检查项,四类新药静脉注射用的己酮可可碱氯化钠注射液设计了有关物质项。采用HPLC法检测有关物质,其分离效果及最低检测限均优于TLC法。 1.仪器与试药 Waters600E型高效液相色谱仪(美国Waters公司),NOVa—PaKC18预柱+NOVa - PaK3.9×150mm;U—2000型可见紫外分光光度计(日本日立公司);己酮可可碱对照品(石家庄制药集团有限公司);己酮可可碱氯化钠注射液(0.1g/100ml)山东医科大学医药保健品科技开发公司;甲醇(色谱纯);氯仿及乙酸乙酯均为A.R;水为超纯水。
Pentoxifylline is a drug that dilates blood vessels and improves microcirculation. There are no related items in the injection and the related substances are designed for the four types of new drugs, pentoxifylline sodium chloride injection for intravenous injection. HPLC method for the detection of related substances, the separation effect and the minimum detection limit are better than the TLC method. 1. Instruments and reagents Waters600E high performance liquid chromatography (Waters Corporation, USA), NOVa-PaKC18 column + NOVa - PaK3.9 × 150mm; U-2000 visible UV spectrophotometer (Japan Hitachi) Pentoxifyllin Sodium Chloride Injection (0.1g / 100ml) Shandong Medical University Health Science and Technology Development Corporation; Methanol (chromatography pure); Chloroform and ethyl acetate are AR; water is ultrapure water.