HPLC法测定盐酸雷尼替丁注射液的含量及其有关物质  

Determination of Ranitidine Hydrochloride Injection and Its Related Substances by HPLC

作　　者：吴芳花 雷毅[2] 

机构地区：[1]广东省河源市药品检验所,河源517000 [2]广东省药品检验所

出　　处：《中国药事》2010年第12期1216-1218,1250,共4页Chinese Pharmaceutical Affairs

摘　　要：目的采用HPLC法测定盐酸雷尼替丁注射液的含量及其有关物质。方法采用Phenomenex LunaC18柱;检测波长为230nm;流动相采用磷酸盐缓冲液-乙睛（pH7.1）梯度洗脱,流速为1.5mL·min^-1;柱温为35℃。结果盐酸雷尼替丁在0.05211-0.1737mg·mL^-1范围内,峰面积与测定浓度呈良好的线性关系,r=1.000;加样平均回收率为99.5%;重复性试验RSD为0.71%;最低检测限为1.1ng。结论该方法简便、准确、可行,可用于盐酸雷尼替丁注射液的质量控制。Objective To establish HPLC method for determination of Ranitidine Hydrochloride Injection and its related substances.Methods Use a Phenomenex Luna column packed with octadecylsilane bonded silica gel.Detection wavelength was 230nm.The mobile phase consisted of a mixture of phosphate buffer and acetonitrile（pH 7.1）.Gradient elution was used at a flow rate of 1.5mL per minute.The column temperature was 35℃.Results The calibration curve of ranitidine hydrochloride was linear within the range of 0.05211～0.1737mg·mL^-1（r=1.000）.The mean recovery rate was 99.5%.The RSD of precision was 0.71%.The detection limit was 1.1ng.Conclusion The method is simple,accurate and reproducible.It can be used to control the quality of Ranitidine Hydrochloride Injection.

关 键 词：HPLC 盐酸雷尼替丁注射液 含量 有关物质 

分 类 号：R917[医药卫生—药物分析学] R927.2[医药卫生—药学]