复方布洛芬软胶囊中2组分溶出度的测定方法研究

Study on Dissolution of Ibuprofen and Paracetamol in Soft Capsules

目的 :建立同时测定复方布洛芬软胶囊中布洛芬和对乙酰氨基酚2组分溶出度的方法。方法 :以磷酸盐缓冲液 (pH=7 2)为溶剂 ,转速为75r/min ,取样时间为45min ,采用反相高效液相色谱法测定布洛芬和对乙酰氨基酚的溶出度 ,其中色谱柱为氰基柱 ,流动相为磷酸盐缓冲液 (pH=6 6) -甲醇 (60∶40) ,流速为1 0ml/min ,检测波长为223nm ,柱温为30℃。结果 :对乙酰氨基酚与布洛芬检测浓度线性范围分别为0 17～100 14μg/ml(r=0 9999 ,n=9)、0 21～124 86μg/ml(r=0 9999 ,n=9) ;平均回收率分别为99 62 %(RSD=0 36 %)、99 79 %(RSD=0 49 %)。结论 :本方法简便、快速、准确、可靠 ,能同时测定复方布洛芬软胶囊中2组分的溶出量。

OBJECTIVE:To determine the dissolution of ibuprofen and paracetamol in soft capsules.METHODS:Phosˉphate buffer(pH=7.2)was taken as a solvent with the rotating speed set at75/min,and sample taken time was45minutes.The dissolution degree of ibuprofen and paracetamol in soft capsules were determined by a RP-HPLC method.The chroˉmatographic column was CN column;the mobile phase was phosphate buffer(pH=6.6)-methanol(60∶40)with a flow rate of1.0ml/min,the detection wavelength at223nm and the column temperature at30℃.RESULTS:The linear calibration curves were obtained with a range of0.17～100.14μg/ml for paracetamol(r=0.9999,n=9)and0.21～124.86μg/ml for ibuprofen(r=0.9999,n=9)respectively;the average recoveries of the two compounds were99.62%(RSD=0.36%)and99.79%(RSD=0.49%)respectively.CONCLUSION:The determination method is simple,rapid,accurate and reliable,which can be applied to measure the dissolution content of ibuprofen and paracetamol in soft capsules satisfactorily.