【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。更多还原

【Abstract】 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.更多还原