Tobramycin raw material and related preparation impurity spectrum analysis method

• Main Authors: LYU DANDAN, LIU YAQIAN, QIN FENG, ZHANG HANZHI, LIU HAO, FAN DI, ZHAO JINGDAN
• Format: Patent
• Language: Chinese; English
• Published: 22.09.2020
• Subjects: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; PHYSICS; TESTING

The invention discloses a tobramycin raw material and related preparation impurity spectrum analysis method. A post-column derivatization-high performance liquid chromatography fluorescence detectionmethod is adopted. The analysis method disclosed by the invention adopts a post-column derivatization-high performance liquid chromatography fluorescence detection (HPLC-FLD) method, has the advantages of high reaction speed, no interference of a derivatization reagent on measurement and the like, can effectively separate process impurities and degraded impurities through screening and optimization of chromatographic conditions, and is relatively high in sensitivity at the same time, analyzes on samples with complex matrixes, such as suspension type eye drops and eye cream, proves that the method is good in specificity and high in generalizability. 本发明公开了一种妥布霉素原料及相关制剂杂质谱的分析方法，采用柱后衍生化-高效液相色谱荧光检测法。本发明的分析方法采用柱后衍生化-高效液相色谱荧光检测(HPLC-FLD)法，具有反应速度快、衍生化试剂不干扰测定等优点，并且经色谱条件的筛选和优化，可有效分离工艺杂质和降解杂质，同时灵敏度较高；对基质复杂的样品，如混悬型滴眼液、眼膏等分析，