光纤传感过程监测盐酸曲唑酮片溶出度

Fiber Optic Sensing Process Monitoring of Dissolution Rate for Trazodone Hydrochloride Tablets

目的建立在线过程监测盐酸曲唑酮片溶出度的方法。方法采用桨法,以FODT-601型光纤药物溶出度实时监测仪监测盐酸曲唑酮片在0.01 mol·L^(-1)的盐酸溶液中的溶出情况,转速为50 r·min^(-1),检测波长为245 nm。结果盐酸曲唑酮在11.21~67.26μg·m L^(-1)(探头规格2 mm)和5.59~33.51μg·m L^(-1)(探头规格5 mm)的浓度范围内,吸光度和浓度的线性关系良好。国内A厂与进口盐酸曲唑酮片的溶出过程存在明显差异。结论所建立的溶出度检测方法简便、准确、结果可靠,可用于盐酸曲唑酮片溶出度的实时监测。

OBJECTIVE To establish an on-line monitor method for the determination of the dissolution of trazodone hydrochloride tablets. METHODS The drug dissolution concentration was detected by paddle method in 0. 01 mol·L^-1hydrochloric acid solution at the rotational speed of 50 r·min^-1using the Fiber-Optical Dissolution Test（ FODT） System in 245 nm. RESULTS The linear relationship between absorbance and concentration is good for trazodone hydrochloride in the range of 11.21-67.26 μg·m L^-1（ 2 mm probe） and 5.59- 33.51 μg·m L^-1（ 5 mm probe）. The dissolution of domestic trazodone hydrochloride tablets is obviously different from that of an imported drug. CONCLUSION For in process control,the FODT method is simple,accurate,reliable,and it can be used to determine the real dissolution of trazodone hydrochloride tablets.