Aurobindo Pharma Limited, Research Centre, 313 Bachupally, Qutubullapur Mandal, Hyderabad 500 090, India.
J Pharm Biomed Anal. 2011 Feb 20;54(3):582-7. doi: 10.1016/j.jpba.2010.09.016. Epub 2010 Sep 19.
A new degradant of sultamicillin drug substance was found during the gradient reverse phase HPLC analysis of stability storage samples. The level of this degradant impurity was observed up to 1.0%. The impurity (formaldehyde adduct with 5-oxo-4-phenylimidazolidin-1-yl moiety) was identified by LC/MS and was characterized by ((1)H NMR, (13)C NMR, 2D-NMR ((1)H-(1)H COSY, NOESY, HSQC and HMBC), LC/MS/MS, MS/TOF, elemental analysis and IR. This impurity was prepared by isolation and co-injected into HPLC system to confirm the retention time.
在对稳定性储存样品进行梯度反相高效液相色谱分析时，发现舒他西林药物物质的一个新降解物。该杂质的水平高达 1.0%。该杂质（5-氧代-4-苯基咪唑烷-1-基部分与甲醛的加合物）通过 LC/MS 进行鉴定，并通过 ((1)H NMR、(13)C NMR、2D-NMR ((1)H-(1)H COSY、NOESY、HSQC 和 HMBC)、LC/MS/MS、MS/TOF、元素分析和 IR 进行了表征。该杂质通过分离和共同注入高效液相色谱系统进行制备，以确认保留时间。
