HPLC考察妥布霉素滴眼液中11种抗氧剂

Study of 11 Antioxidants in Tobramycin Eye Drops by HPLC

关键词:  高效液相色谱法  妥布霉素滴眼液  抗氧剂  包材相容性

Key words:  HPLC  tobramycin eye drops  antioxidant  compatibility between drug and the container

摘要:

目的 建立妥布霉素滴眼液中11种抗氧剂含量的HPLC测定方法，考察包材中抗氧剂向药液的迁移情况。方法 采用以聚合物基质吸附剂为填料的固相萃取小柱，对样品中的抗氧剂进行富集。利用高效液相色谱建立妥布霉素滴眼液包材中抗氧剂BHA、抗氧剂XH-245、BHT、抗氧剂1790、抗氧剂LK-1081、抗氧剂702、抗氧剂3114、抗氧剂1010、抗氧剂330、抗氧剂1076、抗氧剂168含量的方法，进行方法学验证。50℃放置0，5，10 d考察抗氧剂在滴眼液中的迁移情况。结果 11种抗氧剂峰均分离良好，专属性、线性范围、准确度、精密度、耐用性均符合要求。50℃放置5，10 d后，药液中抗氧剂含量有不同程度的提高，其中BHA、XH-245、BHT、3114、1010、1076更明显。结论 所建立的方法灵敏、快速、准确、重复性好，可用于包材中11种抗氧剂向妥布霉素滴眼液中迁移量的监测。

Abstract:

OBJECTIVE To establish an HPLC method for determining the content of 11 antioxidants in tobramycin eye drops, and study the migration of antioxidants from plastic packaging materials to eye drops. METHODS The solid phase extraction column packing with diethenylbenzene polymer was used to concentrate the antioxidants, the HPLC method was set up to determine the contents of antioxidant BHA, XH-245, BHT, 1790, LK-1081, 702, 3114, 1010, 330, 1076 and 168. Putting samples under condition of 50℃ for 0, 5, 10 d to evaluate the antioxidant immigration. RESULTS The 11 antioxidants were well separated. The specificity, the linear range, the precision, the accuracy and the robustness were good. The content of antioxidants were increased after 5, 10 d under 50℃, among which BHA, XH-245, BHT, 3114, 1010 and 1076 had increased significantly. CONCLUSION The method is sensitive, rapid and accurate with good repeatability, which can be used to evaluate the migration of antioxidants from packaging materials and containers to tobramycin eye drops.