高效液相色谱法测定脂质体制剂中依地酸二钠含量OA
Content Determination of Disodium Edetate in Liposomes by HPLC
目的 建立测定脂质体制剂中依地酸二钠含量的高效液相色谱法.方法 色谱柱为YMC Pack C18 柱(250 mm×4.6 mm,5 μm),流动相为 20 mmol/L四丁基溴化铵与 83 mmol/L乙酸钠混合溶液(用磷酸调pH至 4.0)-甲醇(80∶20,V/V),流速为 1.0 mL/min,检测波长为 254 nm,柱温为 30℃,进样量为 20 μL.结果 依地酸二钠的质量浓度在 0.010～0.100 mg/mL范围内与峰面积线性关系良好(R2=1.0000,n=5);定量限为 0.65 μg/mL;精密度、稳定性、重复性、耐用性试验结果的RSD均小于 3%;平均加样回收率为96.46%,RSD为 1.92%(n=9).3 批样品中依地酸二钠的含量均为 0.06 mg/mL.结论 所建立的方法操作简便、重复性好、准确度高,可用于测定脂质体制剂中依地酸二钠的含量.
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.
许风伟;叶露;罗钟明;马润青
杭州高田生物医药有限公司,浙江 杭州 310051杭州高田生物医药有限公司,浙江 杭州 310051杭州高田生物医药有限公司,浙江 杭州 310051杭州高田生物医药有限公司,浙江 杭州 310051
医药卫生
依地酸二钠脂质体制剂高效液相色谱法含量测定
disodium edetateliposome preparationsHPLCcontent determination
《中国药业》 2026 (3)
97-100,4
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