盐酸倍他司汀原料药含量测定方法的改进  

Improvement of the Determination Method of the Content of Betahistine Hydrochloride

作　　者：梁春慧[1] 宋更申[2] 韩彬[2] 

机构地区：[1]河北医科大学第三医院药剂科,石家庄市050051 [2]河北省药品检验所,石家庄市050011

出　　处：《中国药房》2010年第37期3522-3524,共3页China Pharmacy

摘　　要：目的:建立革除汞盐的氢氧化钠电位滴定法测定盐酸倍他司汀原料药的含量。方法:采用Mettler DG111复合电极,以乙醇为溶剂,用氢氧化钠滴定液(0.1mol·L-1)滴定。同时与《中国药典》2005年版方法即加醋酸汞的高氯酸滴定指示剂法结果比较。结果:盐酸倍他司汀称样量线性范围为0.01008～0.2015g(r=1.0000),最低检测限为1.01mg,平均回收率为99.9%～100.0%。2种测定方法含量结果比较无差异。结论:本方法准确性、线性、重复性等均满足《中国药典》2005年版的相关规定。OBJECTIVE： To establish a mercury-free sodium hydroxide potentiometric titration method for the content determination of betahistine hydrochloride. METHODS： Mettler DG111 was used as the composite electrode with ethanol as solvent and sodium hydroxide （0.1 mol·L-1） as titrating solution. The method was compared with hydrargyrum aceticum titrant followed by perchloric acid titration stated in Chinese Pharmacopeia （2005 edition）. RESULTS： The linear range of betahistine hydrochloride was 0.010 08～0.201 5 g （r=1.000 0） with an average recovery of the 99.9%～100.0%. The lowest detection limit was 1.01 mg. There was no difference between results of two kinds of methods. CONCLUSION： The accuracy, linearity and reproducibility of the new method is in line with the regulations of Chinese Pharmacopeia （2005 edition）.

关 键 词：盐酸倍他司汀 含量 测定方法 改进 

分 类 号：R927.2[医药卫生—药学] R972