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.
出处
《中国药事》
CAS
2010年第12期1216-1218,1250,共4页
Chinese Pharmaceutical Affairs
关键词
HPLC
盐酸雷尼替丁注射液
含量
有关物质
HPLC
Ranitidine Hydrochloride Injection
determination
related substances
