反相高效液相色谱法测定盐酸倍他司汀原料及制剂含量  

RP-HPLC Determination the Content of Betahistine Hydrochloride Raw Material and Preparation

作　　者：朱永琴[1] 景爱华[2] 吴家凯[3] 雷万军[2] 

机构地区：[1]河南省食品药品检验所,河南郑州450003 [2]河南科技大学医学技术与工程学院,河南洛阳471003 [3]郑州大学化学系,河南郑州450052

出　　处：《河南科技大学学报（医学版）》2009年第4期249-250,257,共3页Journal of Henan University of Science & Technology:Medical Science

基　　金：河南省科技攻关计划项目(072102330011;082102330028);河南科技大学博士启动基金资助项目(09001323)

摘　　要：目的建立反相高效液相色谱(RP-HPLC)法测定盐酸倍他司汀原料及制剂中盐酸倍他司汀含量。方法采用RP-HPLC法检测盐酸倍他司汀,色谱柱:Eclipse Plus C18(4.6mm×250mm,5μm);流动相:水相(0.01mol/L醋酸钠液,含0.04mol/L庚烷磺酸钠,0.2%的三乙胺)—甲醇(70:30),用冰醋酸调pH至3.3;流速1.0mL/min;柱温30℃;检测波长261nm。结果此方法在0.001～0.4mg/mL范围内线性良好,r=1.0。结论本方法快速、灵敏、专属性强,适用于盐酸倍他司汀及盐酸倍他司汀片的含量测定。Objective To establish RP-HPLC method for determination of betahistine hydrochloride and betahistine hydrochloride tablets.Methods RP-HPLC.Eclipse Plus C18 （4.6 mm ×250 mm,5 μm）column was adopted with the mobile phase of sodium acetate buffer （0.01 mol/L,include 0.04 mol/L heptane sulfonate and 0.2% triethylamine,adjust to pH 3.3 with glacial acetic acid）-Methanol （70：30） at a flow rate of 1.0 mL/min.The detection wavelength was set at 261 nm.Results The calibration curve was linear in range of 0.001～0.4mg/mL （r=1.0）.Conclusion The method is simple,accurate and sensitive,and can control the quality of the preparation effectively.

关 键 词：高效液相色谱法 盐酸倍他司汀 含量测定 

分 类 号：R927.2[医药卫生—药学]