泮托拉唑钠肠溶片溶出度测定方法学验证

Methodological Validation of Solubility of Pantoprazole Sodium Enteric Tablets

目的对自制泮托拉唑钠肠溶片溶出度测定进行方法学验证,同时与市售产品进行对比研究。方法参考美国药典中泮托拉唑钠肠溶片溶出度测定方法,采用紫外分光光度法测定样品中药物吸光度,并对该方法进行了方法学验证。结果应用紫外分光光度法测定样品吸光度,溶出介质、辅料和滤膜吸附对测定无干扰,药物浓度在1~25μg/m L范围内线性关系良好,回收率在95%~101%内,精密度RSD<2%,样品在四小时内稳定性良好。结论该方法能够准确测定自制泮托拉唑钠肠溶片的溶出度,泮托拉唑钠肠溶片的耐酸力和溶出度均符合要求,与已上市参比制剂的释放行为相似。

Objective To methodologically validate a dissolution method for pantoprazole sodium enteric tablets. The self-made pantoprazole sodium enteric tablets was compared with reference listed drug. Methods The detection was carried out following the procedure described in the second method in United States Pharmacopoeia. The solubility of pantoprazole sodium enteric tablets was detected with ultraviolet spectrophotometry. We methodologically validated the dissolution method. Results The dissolution media, excipients and membrane adsorption did not interferer the determination of pantoprazole sodium in samples by UV. It showed good linearity in drug concentration from 1 ~g/mL to 25 ~g/mL. The recoveries ranged from 95 % to 102 %. The RSD of precision were less than 2 % and the sample was stable in 4 hours. Conclusions The UV method is reliable .The drug release rate of self-made pantoprazole sodium enteric tablets is similar to reference listed drug.