阿替洛尔片的有关物质研究和质量评价  

The related substance research and quality evaluation for Atenolol Tablets

作　　者：闫研 秦斌 殷果 王思明 王铁杰 

机构地区：[1]深圳市药品检验研究院,深圳药品质量标准研究重点实验室,广东深圳518057

出　　处：《药学研究》2017年第11期646-648,663,共4页Journal of Pharmaceutical Research

基　　金：2015年国家药品计划抽验项目资助

摘　　要：目的优化阿替洛尔片的有关物质检查方法,对国内13家企业生产的171批次阿替洛尔片进行有关物质研究和质量评价。方法采用高效液相色谱法,色谱柱为X-bridge C18(4.6 mm×250 mm,5μm),流动相为磷酸盐缓冲液-甲醇(60∶40),检测波长为226 nm,流速为0.6 m L·min-1,柱温为30℃,进样量为20μL。结果阿替洛尔及其有关物质分离良好;171批样品共检出4个杂质(杂质1~4),其中杂质2~4为原料引入,杂质1为片剂特有;阿替洛尔与乳糖、氯乙酸均未反应生成杂质。结论本文优化后的方法可以有效地分离分析阿替洛尔及其有关物质,对完善质量标准,加强药品质量控制具有重要意义。Objective To optimize the method for examination of related substance in Atenolol Tablets,and carry out the related substance research and quality evaluation for 171 batches of Atenolol Tablets which produced by 13 domestic company.Methods HPLC separation was carried out on a X-bridge C18 column( 4.6 mm× 250 mm,5 μm) with a mobile phase of phosphate buffer-carbinol( 60 ∶ 40) at a flow rate of 0.6 m L·min-1,the detection wavelength was 226 nm,the column temperature was 30 ℃,and the injection volume was 20 μL. Results Atenolol and its main related substances were well separated.Four impurities( impurity 1 ~ 4) were detected in 171 batches of Atenolol Tablets. The impurity 2 ~ 4 was brought by raw material,impurity 1 was tablet specific impurities. Atenolol were not reaction generated impurities neither with lactose nor chloroacetic acid.Conclusion The optimization method in the article was effective in the separation and identification of the related substances in Atenolol Tablets,which was useful for improvingquality standards and strengthening drug quality control.

关 键 词：阿替洛尔片 有关物质 质量评价 高效液相色谱法 

分 类 号：R927.11[医药卫生—药学]