盐酸特拉唑嗪片有关物质HPLC分析方法的优化  

Optimization of RP-HPLC Method for Determination of Related Substances of Terazosin Hydrochloride Tablets

作　　者：徐勇 陈玲芳[2] 王天莹 来灿林 Xu Yong(Zhejiang CONBA Pharmaceutical Co.,LTD,Hangzhou 310052)

机构地区：[1]浙江康恩贝制药股份有限公司 [2]杭州康恩贝制药有限公司 [3]浙江省中药制药技术重点实验室,浙江杭州310052

出　　处：《黑龙江医药》2020年第6期1228-1231,共4页Heilongjiang Medicine journal

基　　金：浙江省中药制药技术重点实验室(编号:2009E10009)

摘　　要：目的:对中国药典2015年版盐酸特拉唑嗪片质量标准中有关物质检测方法进行优化,使其可用于已知杂质的检测。方法:色谱柱:Agilent Eclipse XDB-C 18色谱柱,流动相为乙腈-高氯酸溶液(20:80),流速1.0mL/min,检测波长246nm,柱温50℃。结果:在优化后的色谱条件下可在较低浓度下准确定量盐酸特拉唑嗪已知杂质a、b、c。各杂质在浓度0.2μg/mL^3.0μg/mL范围内线性关系良好(r>0.999),杂质a、b、c定量限分别为0.6ng、0.9ng、0.8ng,相当于特拉唑嗪的0.006%、0.009%、0.008%。结论:该方法专属性、精密度、准确度良好,可用于更高要求的盐酸特拉唑嗪片有关物质检测。Objective:To optimize the Terazosin Hydrochloride tablets relative substances determination method in the Chinese Pharmacopoeia,in order to determinate the specific impurities.Methods:Agilent Eclipse XDB-C 18 Column was adopted with acetonitrile-perchloric acid(20:80)as mobile phase at flow rate of 1.0 mL/min.The detection wavelength was set at 246 nm and column temperature was 50℃.Results:The quantity of Terazosin impurities(a、b、c)can be accurately determined at a low concentration under this method.The linear range of the impurities were 0.2μg/mL^3.0μg/mL(r>0.999).The quantitative limits of impurity a、b、c were 0.6ng、0.9ng、0.8ng respectively,equivalently to the content of 0.006%、0.009%、0.008%.Conclusion:The method is specific and accurate for determination of Terazosin Hydrochloride tablets relative substances.

关 键 词：盐酸特拉唑嗪片 有关物质 高效液相色谱法 优化 

分 类 号：R927.1[医药卫生—药学]