替莫唑胺有关物质研究  

Research on Related Substances of Temozolomide

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作  者:丁爱忠[1] 成芳[1] Ding Aizhong;Cheng Fang(Technology Center,Jiangsu Tasly Diyi Pharmaceutical Co.Ltd.,Huaian 223002,China)

机构地区:[1]江苏天士力帝益药业有限公司技术中心,江苏淮安223002

出  处:《广东化工》2020年第7期71-72,共2页Guangdong Chemical Industry

基  金:江苏省科技成果转化专项资金项目(BA2004012)。

摘  要:建立了高效液相法测定替莫唑胺的有关物质。采用Welch Materials XB-C18色谱柱,以甲醇:0.5%冰醋酸(4︰96,含0.94 g/L辛烷磺酸钠)为流动相,检测波长270 nm。结果替莫唑胺能与相邻杂质峰较好分离;在0.01033~0.4032μg/mL浓度范围内,其浓度与峰面积的线性关系良好(r=0.9998);有关物质回收率98.46%~101.53%。本法简便,灵敏,重复性好,可用于替莫唑胺有关物质的检测。An HPLC method was established for the determination of temozolomide related substances.The method was carried out on a Welch Materials XB-C18 with a mobile phase consisting of methanol:0.5%glacial acetic acid(4:96,containing 0.94 g/L 1-octanesulfonic acid sodium salt).The detection wavelength was set at 270 nm.There was fair resolution between temozolomide and its related substances.The calibrtation curves were linear over the range of 0.01033μg/ml and 0.4032μg/mL(r=0.9998).The recovery rate of related substances were 98.46%~101.53%.The method is convenient,accurate,reproducible and suitable for the determination of the related substances in temozolomide.

关 键 词:替莫唑胺 高效液相色谱法 有关物质 

分 类 号:TQ460.72[医药卫生—药物分析学] O657.72[化学工程—制药化工]

 

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