愈创甘油醚片溶出度测定方法研究

Study on Determination Method for Dissolution of Guaifenesin Tablets

目的:建立愈创甘油醚片的溶出度测定方法,用于后期评价其内在质量差异。方法:采用桨法,溶出介质为水900 ml,转速为每分钟50转,取样时间为45分钟,采用紫外–可见分光光度法,在274 nm波长下处测定溶出量。结果:在测定波长274 nm处,空白辅料对愈创甘油醚检测无干扰;精密度的RSD为0.29%,线性范围为0.0135~0.081 mg/mL (r = 0.9999),回收率为94.97%~97.27% (RSD = 0.78%, n = 9),在室温条件下5小时内溶出溶液保持稳定。3批愈创甘油醚片的溶出度分别为95.2%、95.1%、95.2%,大于限度要求的85%。结论:该方法简单可靠,重复性好,灵敏度高,可用于测定愈创甘油醚片的溶出度。

Objective: To explore a method for determination of dissolution of guaifenesin tablets, for later evaluation of their intrinsic quality differences. Methods: Using paddle method, the dissolution medium was 900 ml water, the rotation speed was 50 r∙min−1, the sampling time was 45 min, and the dissolution was determined by UV spectrophotometry at 274 nm wavelength. Results: At the wave-length of 274 nm, the blank excipients did not interfere with the detection of guaifenesin. The RSD of precision was 0.29%, the linear range was 0.0135~0.081 mg/mL (r = 0.9999), the recoveries were 94.97%~97.27% (RSD = 0.78%, n = 9), and the solution remained stable within 5 hours at room temperature. The dissolution rates of the three batches of guaifenesin tablets were 95.2%, 95.1% and 95.2%, respectively, which were higher than the limit requirement of 85%. Conclusion: The method is simple, reliable, repeatable and sensitive, and can be used to determine the dissolution of guaifenesin tablets.