目的研究苯二氮牻类药物奥沙西泮的降解产物。方法对奥沙西泮进行强酸、强碱、光、热、氧化条件下的强制破坏实验,采用高效液相色谱法,以不同的流动相系统确认其可能降解产物,并采用制备薄层色谱(PTLC)对其在热破坏条件产生的一个共同降解产物进行分离纯化,并利用UV,IR,¹H-NMR,¹³C-NMR,HMBC,HMQC,ESI-MS等光谱学方法进行结构鉴定。结果分离并制备了奥沙西泮的一个降解产物并确证其结构为6-氯-4-苯基-喹唑啉-2-醛。结论该化合物为奥沙西泮的降解产物,在国内首次报道,为《中国药典》中奥沙西泮的质量标准提高提供了科学依据。

OBJECTIVE To study the decomposable compound of oxazepam.METHODS Destroy-tests of strong acid,strong alkali,highlight,heat and oxygen were used for oxazepam,then the possible decomposable compounds wre elucidated by HPLC under different mobile phases.The mutual decomposable compound under thermal destruction-test was isolated and prepared by Preparative Thin-layer Chromatogram(PTLC)and its structure was elucidated by UV,IR,¹H-NMR,¹³C-NMR,HMBC,HMQC,ESI-MS.RESULTS One decomposable compound(6-Chloro-4-phenyl-quinazoline-2-carbaldehyde)was isolated and identified as the related substance of oxazepam.CONCLUSION The compound was reported in domestic literature for the first time,providing reference for the improvement of oxazepam standard of Chinese pharmacopoeia.