| Establish a HPLC method for determination of assay and related substance for Famciclovir decarboxylated compound.Investigation of Detection wavelength,chromatographic column,column temperature,mobile phase & Elution conditions,chromatographic system,etc,and establish analysis method for determination of Famciclovir decarboxylated compound and related substances and performed the methodology validation.Method for determination of assay and related substances in Famciclovir decarboxylated compound : Chromatographic column: Luna 5 μ Phenyl-Hexyl,250×4.6 mm,5 μm;column temperature: 25 ℃;detection wavelength: UV,221 nm;injection volume: 5 μL;mobile phase: acetonitrile and water;gradient elution: 0-2 min,acetonitrile ratio 12%,2-15 min,acetonitrile ratio 12 %-20%,15-20 min,acetonitrile ratio 20%-40%,20-28.5 min,acetonitrile ratio 40%,28-28.5 min,acetonitrile ratio 40%-12%,28.5-36 min,acetonitrile ratio 12%.In this condition,each impurity can be effectively separated,the resolution between Famciclovir decarboxylated compound and N-7 Famciclovir decarboxylated compound is more than 2.0,the resolution between known impurities is more than 2.0,the sensitivity of method is high,the LOQ of 2-amino-6-chloropurine is 62 ppm,the LOQ of N-7 Famciclovir decarboxylated compound is 376 ppm,the LOQ of Ethyl ester decarboxylated compound is 228 ppm,the LOQ of Diethyl decarboxylated compound is 242 ppm,the LOQ of Famciclovir condensed compound is 356 ppm,and the recovery is between 80%~120%,meanwhile,the linearity and range is wide,repeatability and Intermediate precision is good.The test results show that the HPLC method is suitable for determination of assay and related substances of Famciclovir decarboxylated compound.This method is sensitive and accurate,these impurities are common in current process,so the research in this paper has a certain reference value in this area,and this method has been used for testing the product in enterprise. |
PDF Full Text Request