论文部分内容阅读
A novel in vitro dissolution profile was developed for formulated drug in combinational form containing naproxen sodium ( NAP) and sumatriptan succinate ( SUMA). This study was performed to understand the dissolution of the drug in the physiological temperature and pH. Dissolution testing was performed using USP 29 type II testing apparatus rotating at 50 r /min,in 900 mL deaerated buffer (pH 1. 2,4. 5 and 6. 8) which was maintained at ( 37 ± 0. 5) ℃. Quantification was performed using a developed and validated high performance liquid chromatographic (HPLC) method. Aceclofenac (ACE) was used as internal standard. SUMA,ACE and NAP w ere eluted at 4. 8,5. 7 and 7. 9 min,respectively. As expected for enteric coated immediate release (IR) tablets,the dissolution of NAP and SUMA was rapid and essentially complete within 2 h using phosphate buffer ( pH 6. 8). The comparison of the dissolution profiles was realized by model independent approach using a difference factor ( f1) ,similarity factor (f2) and dissolution efficiency ( DE). Statistical results show ed the pro-files were similar to the reference and the test products. Hence,this method demonstrated to be adequate for in vitro studies of NAP and SUMA in the combinational dosage form,since there is no official monograph,col-laborating to the official codes.
A novel in vitro dissolution profile was developed for formulated drug in combinational form containing naproxen sodium (NAP) and sumatriptan succinate (SUMA). This study was performed to understand the dissolution of the drug in the physiological temperature and pH. Dissolution testing was performed using USP 29 type II testing apparatus rotating at 50 r / min in 900 mL deaerated buffer (pH 1. 2,4. 5 and 6. 8) which was maintained at (37 ± 0.5) ° C. Quantification was performed using a developed and validated high performance liquid chromatographic (HPLC) method. Aceclofenac (ACE) was used as internal standard. SUMA, ACE and NAP wrere eluted at 4.8.5.7 and 7. 9 min, respectively. As expected for enteric coated immediate release (IR) tablets, the dissolution of NAP and SUMA was rapid and essentially complete within 2 h using phosphate buffer (pH 6.8). The comparison of the dissolution profiles was realized by model independent approach using a difference factor (f1 ), similarity f actor (f2) and dissolution efficiency (DE). Statistical results show the pro-files were similar to the reference and the test products. Therefore, this method demonstrated to be adequate for in vitro studies of NAP and SUMA in the combinational dosage form , since there is no official monograph, col-laborating to the official codes.