摘要
目的建立适合盐酸雷尼替丁胶囊有关物质的HPLC的定量检测法。方法phenomenexLuna5μC18(2)250×4.60μm;检测波长320nm;流动相:甲醇∶醋酸胺(42∶58);自身对照法。结果其有关物质的峰面积之和不超过对照品主峰面积的3倍,最大杂质峰不超过对照品主峰峰面积的1.5倍。结论本方法能灵敏、准确、可靠的进行杂质检测,对盐酸雷尼替丁胶囊有关物质的控制有一定的意义。
OBJECTIVE To establish a high performance liquid chromatography method for determination of Ranitidine Hydrochloride Capsules' related impurity.METHODS Method The analytical column was phenomenex Luna 5μ C 18(2)250×4.60μm.The mobile phase was CH 3OH∶CH 3COONH 4(0.1mol·ml -1)(42∶58).The detection wavelength was set at 320nm.RESULTS Sum areas of Ranitidine Hydrochloride Capsules' related impurity is no 3 times wider than its control main area, the biggest area of Ranitidine Hydrochloride Capsules' related impurity is no 1.5 wider times than its control main area.CONCLUSION The method is sensitivity, accurate, and reliable.
出处
《海峡药学》
2005年第2期48-51,共4页
Strait Pharmaceutical Journal
