HPLC法检查盐酸雷尼替丁胶囊中有关物质  

HPLC DETERNINATION ON TEST FOR RELATED SUBSTANCES OF RANITIDINE HYDROCHLORIDE CAPSULES

作　　者：陈祖芬[1] 王锦文[2] 

机构地区：[1]云南省药品检验所,昆明650011 [2]云南省红十字会医院,昆明650011

出　　处：《中国药品标准》2002年第4期45-47,共3页Drug Standards of China

摘　　要：目的:建立测定盐酸雷尼替丁胶囊有关物质的高效液相色谱法。方法:采用惠普1100型,C_(18)色谱柱(5μm250×4.6mm),以0.1mol·1^(-1)醋酸铵-甲醇(64:36)为流动相,用二极管阵列检测器于320um波长处测定。结果:盐酸雷尼替丁与其它杂质峰完全分离,从而对其有关物质进行限量检查。结论:此法较中国药典现行的TLC法操作准确、简便,影响因素少,并可在同一色谱条件下进行含量测定及有关物质检查。Objective To establish HPLC method for the determination of related substances in Rani-tidine Hydrochloride Capsules. Method: Using a C_(18) column(5μm, 4.6×250mm);0.1mol·l^(-1) ammoniumacetate-methanol (64:36)as mobile phase and detection wavelegth of 320nm. Results: Keep the Raniti-dine Hydrochloride Capsules peak separated from the related substances completely and determine the limit of the main impurity. Conclusion: The method is rapid,simple and accurate.

关 键 词：高效液相色谱法 盐酸雷尼替丁胶囊 含量测定 药品检验 

分 类 号：R927[医药卫生—药学]