光纤传感过程检测氯硝西泮片的溶出度

Process analysis on of the dissolution of Clonazepam Tablets by fiber-optic sensor

目的建立过程分析氯硝西泮片溶出度的方法。方法采用光纤药物溶出度实时测定仪(FODT)测定氯硝西泮片的溶出度,并进行方法学考察和平行HPLC对照实验。结果 FODT测定氯硝西泮片溶出度与HPLC法测定结果比较,差异无统计学意义。结论利用FODT过程检测氯硝西泮片溶出度,能全面直观地反映药品的释放过程和批内品质,较经典方法能提供更多信息,测定过程简便自动,测定结果准确可靠。

Objective To establish a method which can on-line test the dissolution of Clonazepam Tablets. Methods According to process analysis, the dissolution of Clonazepam Tablets was determined by fiber-optic dissolution test system（FODT） and com- pared with HPLC controlled trials. Results There were no significant difference in detecting the dissolution of Clonazepam Tab- lets by FODT and HPLC. Conclusion Analyzing the dissolution of Clonazepam Tablets by FODT can fully and directly reflect the release procedure and within-lot quality of medicine. This method was simple, automatic, accurate and reliable, and can provide more information compared with the classical method.