Compatibility of hollow hydroxypropyl starch capsules with drug particles of ofloxacin / 中国药学杂志

ABSTRACT

OBJECTIVE: To investigate the compatibility of hollow hydroxypropyl starch capsules with drug particles of ofloxacin. METHODS: The capsules were placed in conditions of high temperature of 40℃ or high humidity of (75 ± 5)% RH for 5 and 10 d, respectively. The contents and related substances were determined by high performance liquid chromatography (HPLC), and the changes in the drug appearance and colors were observed. RESULTS: After being stored under the conditions of high temperature and high humidity for 5 and 10 d, the contents of ofloxacin were in the range of 90% - 110%, and no new impurities were detected, which conformed to the quality standard of ofloxacin capsules in the Chinese Pharmacopoeia 2010 edition. CONCLUSION: There is good compatibility between ofloxacin and hollow hydroxypropyl starch capsules, which is consistent with the test results of gelatin capsules.