HPLC法测定复方依那普利片累计溶出度

HPLC method for assay of accumulative dissolution of compound enalapril tablets

目的:复方依那普利药物中的有效成分为马来酸依那普利与氢氯噻嗪,本研究采用HPLC法测定复方依那普利的累计溶出度。方法:采用LUNAC18柱,甲醇—乙醚—三乙胺—水(3:0.025:0.01:20)为流动相,检测波长为215nm和272nm。结果:含量测定方法较好地分离被测组分和有关杂质,被测组分的线性关系很好,回收率满意,溶出度为90%以上。结论:此质量标准能很好地控制成品质量。

OBJECTIVE:Effective constituents contained in the compound enalapril tablets are enalapril maleate and hydrochlorlthiazide.Accumulative dissolution of the compound tablets was determined by HPLC method and the accumulative dissolution chart was drawn METHODS: The LUNA C18column was used.The mobile phase consisted of phasphate Buffer—Triethy- lamine—water(3:0.025:0.01:20),and detection wavelength 215nm and 272nm RESULT Im- purity had no influnce on the assay of the components.The linera been used to determine com- pound maleate enalapril tablets was high reproducibility The recovery was satisfactory.the disso- lution limit was over 90% of content.Conlusion This quality standard was capable to effectively control real quality of compound liquid chromatography HPLC.