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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。
OBJECTIVE To establish a HPLC method for simultaneous determination of antioxidants 1010, 330, 168, and 1076. Four antioxidants in five-layer co-extruded film for infusion solution were determined. Antioxidants were also injected into 0.9% sodium chloride Liquid migration. Methods RP-HPLC method was used. The column was Eritrea C18 column (250 mm × 4.6 mm, 5 μm) with acetonitrile-tetrahydrofuran-water (63:30:7) as the mobile phase at a column temperature of 30 ℃ with a volume flow rate of 1 mL / min. Detection wavelength 276nm, injection volume 10μL. Results The antioxidants 1010, 330, 168 and 1076 showed good linearity in the range of 0.6 ~ 253.6,0.6 ~ 246.4,0.6 ~ 257.6,0.6 ~ 251.6μg / mL with average recoveries of 90.70% (RSD = 2.35%) and 89.11% (RSD = 2.75%), 89.87% (RSD = 3.01%), 92.78% (RSD = 1.81%). The anti-oxidants 1010, 330, 168, 1076 in the film of five-layer co-extruded film were also determined. The established HPLC method has good stability and high accuracy and can be used for the determination of antioxidants in the five-layer co-extruded film . Conclusion The quantities of four antioxidants in the membranes and raw materials for infusion are in line with the European Pharmacopoeia standards, migration test was not detected in 0.9% sodium chloride injection.