Objective:To establish an assay method for the determination of viral particle(VP)in herpes simplex virus injection by AEX-HPLC.Methods:The HPLC was run on Resource Q column with gradient elution using Tris buffer(20 mmol/L,pH 7.0)as mobile phase A and Tris buffer containing 2.5 mol/L NaCl as mobile phase B.The assay method was subsequently validated.Results:There was no interference peak in the blank solvent and the resolution between peaks for herpes simplex virus and other impurities in the unpurified herpes simplex virus solution was greater than 1.5.The LOQ and the LOD of this assay were 5.0×107 and 2.0×107 VP/mL.The linearity relationship between the concentration and the absorption peak was good in the range of 5×107-1×109 VP/mL with R2 0.998 2.RSD%in precision assay was 0.9%and recovery in accuracy assay was between 70%-130%.Conclusion:The AEX-HPLC assay can be applied to determine the viral particle in herpes simplex virus injection.
维普
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