Content Determination of Mannitol in NMM Anti-Tumor DNA Vaccine by HPLC-RID
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.
NMM anti-tumor DNA vaccinerecombinant biological productsmannitolHPLCRIDcontent determination
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