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(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 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.
出处
《药物评价研究》
CAS
2012年第5期354-358,共5页
Drug Evaluation Research
关键词
五层共挤膜输液用膜
抗氧化剂
HPLC
five-layer co-extrusion films used for infusion
anti-oxidant
HPLC
