期刊论文

Content Determination of Amodiaquine Hydrochloride Tablets and Related Substances by HPLC

中文

中国药房

China Pharmacy

1001-0408

2013

23

21

2007-2009

本校为第一机构

目的:建立测定盐酸阿莫地喹片含量和有关物质的方法。方法:采用高效液相色谱(HPLC)法,并与该制剂国家标准中的薄层色谱(TLC)法检测有关物质和紫外-可见分光光度法(UV)测定含量的结果进行比较。色谱柱为Insteril ODS-3,流动相为缓冲溶液[水-三乙胺-磷酸(100 ∶1 ∶0.5)]-甲醇(75 ∶25),流速为1.0 ml/min,检测波长为342 nm,柱温为30 ℃。结果:盐酸阿莫地喹检测质量浓度线性范围为10.06~100.55 μg/ml(r=0.999 9),平均回收率为99.56%,RSD=0.87%(n=9),定量限和检测限分别为6.7、0.4 ng。2种含量测定方法结果相似,RSD分别为0.60%、0.71%;2种有关物质测定方法中TLC法未检出杂质,HPLC法测定总杂质量为0...

OBJECTIVE：To establish a method for the determination of Amodiaquine hydrochloride tablets and related substances.METHODS：HPLC method was adopted and compared with results of TLC and UV in national standard.The determination was performed on Insteril ODS-3 C18 column with mobile phase consisted of water-triethylamine-phosphoric acid（100：1：0.5）-methanol（75：25）at the flow rate of 1.0 ml/min.The detection wavelength was set at 342 nm,and column temperature was 30 ℃.RESULTS：The linear range of amodiaquine hydrochloride was 10.06-100.55 μ...