复方电解质葡萄糖注射液M3B与R4A中5-羟甲基糠醛检查方法学研究  

Study on the detection method of 5-Hydroxymethyl-2-Furaldehyde as an impurity in Compound electrolyte-glucose-M_3B Injection and in Compound electrolyte-glucose-R_4A Injection

作　　者：倪维芳[1] 金瓯[1] 吴薇[1] 

机构地区：[1]浙江省药品检验所,杭州310004

出　　处：《中国药品标准》2004年第4期39-41,共3页Drug Standards of China

摘　　要：目的:建立用紫外分光光度法控制复方电解质葡萄糖注射液M3B与R4A中5-羟甲基糠醛杂质的限量。方法:采用HPLC法及紫外分光光度法对二个品种的纯度检查方法进行了研究。结果:紫外分光光度法及HPLC法均能有效控制样品中5-羟甲基糠醛杂质的限量。结论:紫外分光光度法快速、简便,可作为产品的质量控制方法。Objective:to set up a UV method to control the 5-Hydroxymethyl-2-Furaldehyde in Compound-electrolyte-glucose-M3B Injection and in Compound electrotyte-glucose-R4A Injection. Method ;UV as well as HPLC was used on this study as im-purity control method for these two injections. Result:the UV method and HPLC method were all proved to be effective methods for the control of the quantity of 5-Hydroxymethyl-2-Furaldehyde as an impurity in the injections. Conclusions:a fast and convenient UV method can be used as a quality control method of 5-Hydroxymethyl-2-Furaldehyed in Compound-electrolyte-glucose-M3B Injection and in Compound electrolyte-glucose-R4A Injection.

关 键 词：紫外分光光度法 葡萄糖注射液 5-羟甲基糠醛 复方 HPLC法 检查方法 电解质 法学研究 有效控制 

分 类 号：R927[医药卫生—药学] R286.0