HPLC法测定尼可刹米中有关物质.PDFVIP

2008 226 481 HPL 1 1 2 1 孙 卫, 刘 珠 , 赵秀红, 高振强 ( , 050015; ; 2 ) : 建立HPL 法测定尼可刹米中有关物质采用 Diamonsil 18色谱柱, 以甲醇- 水 ( 30 70) 为 1 流动相; 检测波长263nm; 流速10mL min 效液相色谱法测定尼可刹米中有关物质, 降解产物与 主峰达到有效分离, 样品测定符合规定该法操作简便, 结果准确, 专属性强, 可用于尼可刹米原料中的 有关物质的测定 : 效液相色谱法; 尼可刹米; 有关物质 : R9272 : A :(2008) Determinnation of Related Substance in Nikethamide by HPLC 1 1 2 Sun Wei, Liu Zhu , Zhao Xiuhong and Gao Zhenqiang (North hina Pharmaceutical o. , Ltd. , Shijiazhuang 1 2 050015; Hebei Provincial Institude for Drug ontrol; Third Hospital, Hebei Medical University) ABSTRACT A HPL method was established to determine related substance in Nikethamide. The analisis was conducted with Diamonsil 18 column at room temperature, the mobile phase was consisted of methanol- water 1 (3070) , the detecting wavelength was 263nm, the flow was 10mL min . Nikethamide WAS Separated with its related substance thoroughly. The sample was analysed. The method is proved to be accurate and reliable cound be use for anslysis of the related substance in Nikethamide. KE WORDS HPL ; Nikethamide; related substance , # 200nm, 5m) ; : (3070) , [ 1] [ 2] [ 3] 1 G : 263nm; : 10mL min ; [4] , HPL : 10L; : [ 5] , !∀ 2005 22 , 221 40mg, 2 , , 1 1 1mol L 2mL, 1 , 1 , 11mol L