中国药业2024，Vol.33Issue(1)：64-67,4.DOI:10.3969/j.issn.1006-4931.2024.01.014
高效液相色谱-示差折光法测定NMM抗肿瘤DNA疫苗中甘露醇含量
Content Determination of Mannitol in NMM Anti-Tumor DNA Vaccine by HPLC-RID
摘要
Abstract
Objective To establish a high-performance liquid chromatography differential refractive index detector(HPLC-RID)method for the content determination of mannitol in NMM anti-tumor DNA vaccines.Methods RID was adopted,the chromatographic column was SUGAR SC1011 cation calcium exchange column(300 mm×8 mm,6 μm),the mobile phase was purified water,the flow rate was 1.0 mL/min,the column temperature was 80℃,the temperature of detection cell was 37℃,and the injection volume was 10 μL.Results The linear range of mannitol was 0.02-5.00 mg/mL(R2 = 1.000 0,n = 6).The limit of quantification(LOQ)was 13.37 μg/mL.The RSDs of precision,repeatability,and stability test results were lower than 2.0%.The recovery rate of mannitol was 97.76%with an RSD of 0.97%(n = 9).The contents of mannitol in three batches of small-test and pilot-test samples were 20.02 mg/mL and 19.95 mg/mL,respectively.Conclusion The method is simple,accurate and specific,which can be used for the content determination of mannitol in NMM anti-tumor DNA vaccines.关键词
NMM抗肿瘤DNA疫苗/重组生物制品/甘露醇/高效液相色谱法/示差折光检测器/含量测定Key words
NMM anti-tumor DNA vaccine/recombinant biological products/mannitol/HPLC/RID/content determination分类
医药卫生引用本文复制引用
郭润姿,黄言,孙澳,于继云,王宇..高效液相色谱-示差折光法测定NMM抗肿瘤DNA疫苗中甘露醇含量[J].中国药业,2024,33(1):64-67,4.基金项目
河北省科学技术厅重点研发计划项目[20372404D]. （）
