HPLC法测定盐酸地巴唑原料及片剂含量  

Content Determination of Dibasol Hydrochloridein Raw Material and Tablets by HPLC

作　　者：陈宇堃[1] 刘逸韬 梁蔚阳[1] Chen Yukun;Liu Yitao;Liang Weiyang(Guangdong Institute for Drug Control,NMPA Key Laboratory for Quality Control of Blood Products,Guangdong Drug Administration Key Laboratory of Quality Control and Research of Blood Products,Guangzhou 510663,China)

机构地区：[1]广东省药品检验所国家药品监督管理局血液制品质量控制重点实验室广东省药品监督管理局血液制品质量控制研究重点实验室,广州510663

出　　处：《中国药师》2020年第7期1449-1452,共4页China Pharmacist

基　　金：广东省食品药品管理局科技项目引导扶持基金(编号:2019ZDZ23、2018YDB02);广东省医学科学技术研究基金项目(编号:B2018130、B2018220)。

摘　　要：目的:建立HPLC法测定盐酸地巴唑原料及片剂含量,并与高氯酸滴定法进行比较。方法:色谱柱:Kromasil C18(250mm×4.6 mm,5μm);流动相:水-甲醇-冰醋酸-三乙胺(45∶55∶0.5∶0.5);流速:1.0 ml·min^-1;检测波长:220 nm;柱温:30℃;进样量:10μl。结果:盐酸地巴唑的线性范围为4.102~205.100μg·ml^-1(r=0.9999),盐酸地巴唑定量限为0.273μg·ml^-1,原料和片剂的回收率分别为101.2%和99.5%,RSD分别为0.9%和1.3%(n=9)。两种方法测定的原料和片剂含量结果无差异。结论:该方法操作简便,专属性强,结果准确,能有效反应药品质量,与高氯酸滴定法测定结果无明显差异,可作为盐酸地巴唑原料及片剂的含量测定方法。Objective:To establish an HPLC method for the content determination of diabasol hydrochloride in raw material and tablets and compare with the perchloric acid titration.Methods:The HPLC method was performed on a column of Kromasil C18(250 mm×4.6 mm,5μm).The mobile phase was water-methanol-acetic acid-triethylamine(45∶55∶0.5∶0.5)at a flow rate of 1.0 ml·min^-1.The detection wavelength was 220 nm,the temperature was 30℃and the injection volume was 10μl.Results:There was a good linearity within the range of 4.102-205.100μg·ml^-1 for dibasol hydrochloride(r=0.9999)by HPLC.The limit of detection was0.273μg·ml^-1.The average sample recovery of dibasol hydrochloride raw material and tablets was 101.2%and 99.5%with the RSD of0.9%and 1.3%(n=9),respectively.There was no difference in the content of raw materials and tablets determination by the two method.Conclusion:The method is rapid,accurate and specific.No significant difference from the results of perchloric acid titration.It can be used to determine the content of dibasol hydrochloride in raw material and tablets.

关 键 词：盐酸地巴唑 含量测定 高效液相色谱法 高氯酸滴定法 

分 类 号：R927.2[医药卫生—药学]