摘要
目的 :研究并建立地塞米松片溶出度的介质及测定方法。方法 :采用转篮法分别以 1%盐酸 ,5 %乙醇溶液 ,10 %乙醇溶液 ,15 %乙醇溶液及磷酸盐缓冲液 (pH =6 6 ) 5种溶出介质进行地塞米松片的溶出试验 ,以HPLC法测定溶出介质中地塞米松的浓度。结果 :研制片与市售地塞米松片在 5 %乙醇溶液中 45min时的溶出度均大于标示量的 79%。结论 :所建立的HPLC方法准确、可靠 ;地塞米松片在 5 %乙醇溶液中的溶出度符合药典要求。
AIM: To establish and evaluate an assay for the dissolution of dexamethason tablets. METHODS: The dissolution tests were performed by a rotating basket method, with 1% hydrochloric acid, 5% alcohol solution, 10% alcohol solution, 15% alcohol solution and phosphate buffer (pH=6.6) as dissolution solvents respectively. The concentration of dexamethasone in dissolution solvents was determined by high performance liquid chromatography (HPLC) method. RESULTS: The dissolution of both kinds of dexamethasone tablets in 5% alcohol solution were both greated than 79% of the labeled amount after 45 min. CONCLUSION: Established method is accurate and reliable for the dissolution test of dexamethasone tablets.
出处
《中国临床药学杂志》
CAS
2003年第1期27-29,共3页
Chinese Journal of Clinical Pharmacy
关键词
地塞米松片
溶出度
高效液相色谱法
dexamethasone tablets
dissolution
high performance liquid chromatography
