Determination of the Content of Entecavir and Its Related Substances by HPLC / 中国药房

ABSTRACT

OBJECTIVE: To establish a HPLC method for the determination of content of entecavir and its related substances. METHODS: The HPLC condition was consisted of a Luna C18 column with a column temperature at 25 ℃, using gradient eluate method, the mobile phase was acetonitrile,with a flow rate of 1.0 mL?min-1 and detection at 254 nm. RESULTS: The calibrated linear curve of entecavir was within 0.033 45～0.167 2 mg?mL-1(r=0.999 98). The average recovery was 100.09%,RSD=0.20%, The content of related substance was 0.54%～1.48%. CONCLUSION: This accurate and reliable HPLC method is applicable for the quality control of entecavir and its related substances.