聚丙烯瓶装氯化钠注射液中抗氧剂迁移量的测定

Determination of the migration of antioxidant in Sodium Chloride Injections packed by polypropylene infusion bottles

目的：采用HPLC法建立聚丙烯输液瓶中抗氧剂1010、抗氧剂1076、抗氧剂168、抗氧剂330的含量测定方法，以及抗氧剂向氯化钠注射液中迁移量的含量测定方法。方法采用DiamonsilTM-C18柱（250mm×4．6mm，5μm）为色谱柱，流动相为甲醇；检测波长为276nm，流速为1．0mL·min-1。结果抗氧剂1010、抗氧剂1076、抗氧剂168、抗氧剂330的质量浓度分别在7．49～299．44，7．78～311．25，8．57～342．61和7．35～294．12μg·mL-1范围内线性关系良好；抗氧剂1010、抗氧剂1076、抗氧剂168、抗氧剂330在聚丙烯输液瓶中及氯化钠注射液中的平均回收率为89．8％～98．8％，RSD为2．4％～4．9％。结论该方法准确、简便、快速，可用于抗氧剂1010、抗氧剂1076、抗氧剂168、抗氧剂330在聚丙烯输液瓶中及氯化钠注射液中迁移量的含量测定。

Objective To establish an HPLC method for the determination of antioxidant 1010 ,1076 ,168 and 330 contained in poly-propylene infusion bottles .Method A DiamonsilTM-C18 column（250 mm × 4 .6 mm ,5 μm） was used .The mobile phase was methanol .UV detection wavelength was set at 276 nm .The flow rate was 1 .0 mL · min-1 .Results Antioxidant 1010 ,1076 ,168 and 330 had good linearity in the range of 7 .49-299 .44 ,7 .78-311.25 ,8 .57-342 .61 and 7 .35-294 .12 μg · mL -1 .The average re-coveries for polypropylene infusion bottles and sodium chloride injection were 89 .8% ~98 .8% ,with RSD 2 .4%-4 .9% .Conclu-sions This method is accurate ,simple ,rapid and suitable for the quality control of antioxidant 1010 ,1076 ,168 and 330 contained in polypropylene infusion bottles .The method also could be used for the study of migration of the antioxidants in Sodium Chloride Injections .