RESUMO
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.
RESUMO
OBJECTIVE: To establish a method for determination of D(-) sulbenicillin sodium in sulbenicillin sodium for injection by HPLC/MS. METHODS: The analysis was performed on a SHIMADZU VP-ODS column with mobile phase consisting of 0.01 mol·L-1 ammonium acetate solution-methanol (90:10) at a flow rate of 0.6 mL·min-1. The detection was performed by Multiple Reaction Monitoring (MRM) scanning mode with ESI negative ion mode. RESULTS: D(-) and L(+) sulbenicillin could be effectively separated. Good liner relationship was achieved when the concentration of D(-) sulbenicillin was in the range of 1.03-51.90 μg· mL-1 (r = 0.9997). The average recovery rate was 99.98% at three levels (RSD = 0.30%, n = 9). CONCLUSION: The MRM method is accurate, reliable, and can be used for the determination of D(-) sulbenicillin sodium in sulbenicillin sodium for injection.