摘要
鉴定盐酸克林霉素棕榈酸酯颗粒的杂质,并详细研究了各杂质在各强制降解条件下的稳定性。采用HPLC-Q-TOFESI-MS/MS法和HPLC外标法。通过二级质谱裂解推断盐酸克林霉素棕榈酸酯颗粒中9种杂质;通过HPLC外标法对杂质棕榈酸和棕榈酸乙酯进行定性;并考察了各杂质在各条件下的稳定性。鉴定了盐酸克林霉素棕榈酸酯颗粒的杂质,并考察了各杂质在不同条件下的稳定性。
Identification of related impurities in clindamycin palmitate hydrochloride granules and the stability of those impurities by stress testing were studied. HPLC-Q-TOF-ESI-MS and external standard method of high performance liquid chromatography were adopted. Result showed that the nine impurities in clindamycin palmitate hydrochloride granules were deduced based on the fragmentation pathway of mass spectrometry. Ethyl palmitate and palmitic acid were determinted by external standard method of HPLC. The stability of each impurity under various conditions was discussed. The impurities of clindamycin palmitate hydrochloride granules were identified and their stability under various conditions was comprehended.
出处
《广州化工》
CAS
2017年第6期123-130,133,共9页
GuangZhou Chemical Industry
基金
广州市科技计划项目(201605151644411)
关键词
盐酸克林霉素棕榈酸酯颗粒
杂质
高效液相串联多级质谱法
强制降解
外标法
杂质的稳定性
clindamycin palmitate hydrochloride granules
impurities
high performance liquid chromatographytandem mass spectrometry
stress testing
external standard method
identification and control of impurities
