中国药业2026，Vol.35Issue(3)：97-100,4.DOI:10.3969/j.issn.1006-4931.2026.03.018
高效液相色谱法测定脂质体制剂中依地酸二钠含量
Content Determination of Disodium Edetate in Liposomes by HPLC
许风伟 1叶露 1罗钟明 1马润青1
作者信息
- 1. 杭州高田生物医药有限公司,浙江 杭州 310051
- 折叠
摘要
Abstract
Objective To establish a high-performance liquid chromatography(HPLC)method for the content determination of disodium edetate in liposomes.Methods The chromatographic column was YMC Pack C18 column(250 mm×4.6 mm,5 μm),the mobile phase was the mixture of 20 mmol/L tetrabutylammonium bromide and 83 mmol/L sodium acetate(adjusted to pH 4.0 with phosphoric acid)-methanol(80∶20,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 254 nm,the column temperature was 30℃,and the injection volume was 20 μL.Results The linear range of disodium edetate was 0.010-0.100 mg/mL(R2=1.000,n=5).The limit of quantification was 0.65 μg/mL.The RSDs of precision,stability,repeatability,and durability test results were all lower than 3%.The average recovery of disodium edetate was 96.46%with an RSD of 1.92%(n=9).The content of disodium edetate in the three batches of samples was 0.06 mg/mL.Conclusion The established method is simple,with good repeatability and high accuracy,which can be used for the content determination of disodium edetate in liposomes.关键词
依地酸二钠/脂质体制剂/高效液相色谱法/含量测定Key words
disodium edetate/liposome preparations/HPLC/content determination分类
医药卫生引用本文复制引用
许风伟,叶露,罗钟明,马润青..高效液相色谱法测定脂质体制剂中依地酸二钠含量[J].中国药业,2026,35(3):97-100,4.
