五层共挤膜输液用膜中4种抗氧化剂的同时测定及迁移研究

目的建立同时测定抗氧化剂1010、330、168、1076的高效液相色谱法（HPLC）,测定五层共挤膜输液用膜中的4种抗氧化剂,并研究抗氧化剂向0.9%氯化钠注射液中的迁移情况。方法采用RP-HPLC方法,色谱柱为伊利特C18柱（250mm×4.6 mm,5μm）,乙腈-四氢呋喃-水（63：30：7）为流动相,柱温30℃,体积流量1mL/min;检测波长276nm,进样量10μL。结果抗氧化剂1010、330、168、1076分别在0.6～253.6、0.6～246.4、0.6～257.6、0.6～251.6μg/mL线性关系良好,平均回收率分别为90.70%（RSD=2.35%）、89.11%（RSD=2.75%）、89.87%（RSD=3.01%）、92.78%（RSD=1.81%）。同时测定五层共挤膜输液用膜中的抗氧化剂1010、330、168、1076,所建立的HPLC法稳定性好、准确度高,可用于五层共挤膜输液用膜中抗氧化剂的测定。结论四种抗氧化剂在输液用膜及原材料中的量均符合欧洲药典标准,迁移试验在0.9%氯化钠注射液中均未检出。

Simultaneous determination and migration of four anti-oxidants in five-layer co-extrusion films used for infusion

Objective To establish a high performance liquid chromatography method for simultaneous determination of anti-oxidants 1010,330,168,and 1076 in five-layer co-extrusion films used for infusion,and to study the migration of anti-oxidants to 0.9% sodium chloride injection.Methods The study was carried out by using RP-HPLC with Yilite C18 column(250 mm × 4.6 mm,5 μm) and acetonitrile-tetrahydrofuran-water(63:30:7) as mobile phase.The column temperature was 30 ℃,flow rate was 1 mL/min,detection wavelength was 276 nm,and injection volume was 10 μL.Results Under the chromatographic conditions used,anti-oxidants 1010,330,168,and 1076 had good linear relationship respectively in the following ranges of 0.6―253.6,0.6―246.4,0.6―257.6,and 0.6― 251.6 mg/L,and the average recoveries were 90.70%(RSD = 2.35%),89.11%(RSD = 2.75%),89.87%(RSD = 3.01%),and 92.78%(RSD = 1.81%).Conclusion This validated method is available for quality evaluation and quality control of anti-oxidants 1010,330,168,and 1076 in five-layer co-extrusion films used for infusion.The contents of four kinds of anti-oxidants in infusion films and raw materials meet the standards of European Pharmacopoeia.The migration contents of anti-oxidants to 0.9% sodium chloride injection are not detected.