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[摘要]
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(250 mm×4.6 mm,5 μm),乙腈-四氢呋喃-水(63∶30∶7)为流动相,柱温30 ℃,体积流量1 mL/min;检测波长276 nm,进样量10 μL。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、0.6~251.6 μg/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。
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[Abstract]
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.
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