Objective To verify and optimize the chromatographic conditions,method specificity,impurity correction factor,impurity relative retention time,minimum detection limit,injection precision,stability and other aspects of the detection of related substances of famciclovir established by a company with reference to USP43.Methods A HPLC method was used with a Agilent Eclipse XDB-C8 column 4.6 mm×150 mm(5 μm),the flow rate was 1.5 ml/min and the injection volume was 20 μl.A C18 HPLC isocratic elution method of Chinese Pharmacopoeia 2020 edition was used.The mobile phase was acetonitrile:0.02 mol/L phosphate buffer(20∶80),the detection wavelength was 221 nm.The mobile phase of enterprise self-designed method was acetonitrile(acetonitrile concentration from 5%to 30%)-0.02mol/L phosphate buffer(pH 4.00±0.05)with gradient elution,the detection wavelength was 220 nm.Results The method has good specificity.The detection limits of impurity A and B of famciclovir were 17.6 ng/ml and 16.8 ng/ml respectively.The method has good sampling precision,and the stability is good,it is recommended to modify the pH value of buffer solution in the mobile phase of the self-designed method to 3.50.Conclusion The method is rapid and simple,and can be used for the detection of related substances of famciclovir in bulk.At the same time,it provides a basis for enterprises to set the impurity control limit.
FamciclovirHigh performance liquid chromatographyRelated substancesSpecificity of methodpH
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