劳拉西泮中杂质6-氯-4-(2-氯苯基)-2-喹唑啉甲醛的定位鉴别研究  

Study on the identification of 6-chloro-4-(o-chlorophenyl) -2-quinazolinecarboxaldehyde in lorazepam

作　　者：王慧[1] 陈华[1] 南楠[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2009年第12期1985-1988,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立劳拉西泮及其片剂中主要杂质6-氯-4-(2-氯苯基)-2-喹唑啉甲醛(杂质C)的鉴别溶液,解决国内缺少该杂质对照品的问题。方法:采用将劳拉西泮用有机溶剂溶解,酸破坏加热降解的方法得到杂质C的鉴别溶液。结果:经HPLC、UV和LC-MS/MS验证,该鉴别溶液中的杂质C与USP杂质对照品结构一致,为同一物质。结论:该方法简便、准确,可用于劳拉西泮及其片剂中主要杂质C的定位鉴别。Objective：To establish the identification solution of the main related compound [6-chloro-4-（o-chlorophenyl）-2-quinazolinecarboxaldehyde,impurity C] in lorazepam and its tablets.To solve the question of lacking impurity C RS.Methods：After dissolving lorazepam in organic solvent with sufficient phosphoric acid and heated,then used the decomposed solution as the identification solution of impurity C.Results：After identified by HPLC,UV and LC-MS/MS,impurity C in identification solution has the same structure as the USP reference substance.Conclusion：The method is simple and accurate,and can be used to identify impurity C in lorazepam and its tablets.

关 键 词：劳拉西泮 6-氯-4-(2-氯苯基)-2-喹唑啉甲醛 有关物质 

分 类 号：R917[医药卫生—药物分析学]