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

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.