Validation and optimization of the method for the detection of related substances of famciclovir
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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