Hiremath Vijay Basayya, Kaliaperumal Krishna, Bhojraj Suresh, Nanjan Mulla Joghee
TIFAC CORE HD, JSS College of Pharmacy, Rocklands, Ooty-643001, Tamilnadu, India.
Se Pu. 2010 Jan;28(1):93-9. doi: 10.3724/sp.j.1123.2010.00093.
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) degrees 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 were 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 showed the profiles 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, collaborating to the official codes.
开发了一种新型体外溶出曲线，用于含萘普生钠（NAP）和琥珀酸舒马曲坦（SUMA）的复方制剂药物。进行本研究以了解药物在生理温度和pH值下的溶出情况。溶出度测试使用美国药典29型II测试装置，以50转/分钟的速度旋转，在900 mL脱气缓冲液（pH 1.2、4.5和6.8）中进行，缓冲液温度保持在（37±0.5）℃。使用已开发并验证的高效液相色谱（HPLC）方法进行定量。双氯芬酸（ACE）用作内标。SUMA、ACE和NAP分别在4.8、5.7和7.9分钟洗脱。正如肠溶包衣速释（IR）片剂所预期的那样，使用磷酸盐缓冲液（pH 6.8）时，NAP和SUMA在2小时内迅速且基本完全溶出。通过使用差异因子（f1）、相似性因子（f2）和溶出效率（DE）的非模型方法实现溶出曲线的比较。统计结果表明这些曲线与参比制剂和受试产品相似。因此，由于没有官方专论，该方法被证明适用于复方剂型中NAP和SUMA的体外研究，符合官方规范。
