HPLC法测定盐酸倍他司汀口服液中的有关物质  

Determination of betahistine hydrochloride oral solution and its related substances by HPLC

作　　者：金秀杰 王冬梅[1] 吴庆芝 李晓倩[1] 张维萍[1] 赵怀清[1] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2015年第3期193-198,212,共7页Journal of Shenyang Pharmaceutical University

摘　　要：目的建立反相HPLC法测定盐酸倍他司汀口服液中有关物质含量。方法采用Diamonsil C18色谱柱(150 mm×4.6 mm,5μm),流动相:p H 4.7的醋酸铵缓冲溶液(650 m L,约含2.88 g十二烷基硫酸钠)-乙腈(体积比为65∶35),流速:1.0 m L·min-1,进样量:20μL,检测波长:261 nm,柱温:40℃。结果在该色谱条件下,3批样品中各杂质质量分数分别为,杂质A(×10-2):6.385%、6.247%、6.164%;杂质B(×10-2):4.901%、4.916%、4.741%;杂质C未检测到;其他单个最大杂质(×10-2):6.329%、5.892%、5.306%;总杂质(×10-1):2.209%、2.119%、2.022%。结论该方法可用于盐酸倍他司汀口服液中有关物质的检查。Objective To develop an HPLC method for determining the related substances of betahistine hydrochloride oral solution. Methods The separation was performed on a Diamonsil C18 column（ 150 mm × 4.6 mm ,5 μm） ,the mobile phase was composed of PH 4.7 acetate buffer solution（2.88 g lauryl sodium sulfate in 650 ml acecate buffer solution） -acetonitrile （ V： V = 65： 35 ）, the flow rate was 1.0 mL· min - 1. The injection volume was 20 μL and the determination wavelength was set at 261 nm. The column temperature was 40 ℃. Results Using this method,not more than 0. 2% of impurity A was found,not more than 0. 2% of impurity B was found,not more than 0.2% of impurity C was found,not more than 0. 1% of the else single maximal impurity was found, and not more than 0.5 % of total impurities was found in three batches samples. Conclusions This method is specific, accurate and sensitive, and it is applicable for the determination of content and related substances of betahistine hydrochloride oral solution.

关 键 词：盐酸倍他司汀 有关物质 反相高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]