Liao Dong-me
2013
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Journal
Chinese Journal of New Drugs
Abstract
Objective: To prepare entecavir dispersible tablets,and to establish a method of quatity control for the dispersible tablets. Methods: Entecavir dispersible tablets were made of lactose,MCC101,PVPK, PVPK30 and others. HPLC method was used to detect drug content,the related substances and its optical isomer. Gradient elution was adopted to separate four kinds of known impurities and other unknown impurities. Enantiomer was separated by chiral column. Results: The composition of the prescription of entecavir dispersible tablets was determined. Entecavir and impurities could be effectively separated. Conclusion: The formula and preparation process of entecavir dispersible tablets are reasonable and simple. Four impurities and one optical isomer can be quickly separated from entecavir by HPLC method,and the impuritiy limits can be effectively controlled.