愈酚维林片的溶出度测定方法研究

发布时间：2018-06-18 12:51

  本文选题：高效液相色谱法 + 愈酚维林片　； 参考：《中国药房》2017年12期

【摘要】：目的:建立愈酚维林片溶出度的测定方法,并比较不同厂家制剂的差异。方法:采用浆法进行溶出,以水为溶出介质,体积为1 000 m L,转速为75 r/min,取样时间为45 min;采用高效液相色谱法测定制剂中枸橼酸喷托维林和愈创甘油醚的溶出度:色谱柱为CAPCELL PAK C_(18)MGⅡS-5,流动相为乙腈-磷酸三乙胺缓冲溶液(p H 2.6±0.05)(33∶67,V/V),流速为1.0 m L/min,检测波长为215 nm(枸橼酸喷托维林)、275 nm(愈创甘油醚),柱温为35℃,进样量为20μL。结果:枸橼酸喷托维林、愈创甘油醚检测质量浓度线性范围分别为5.091 6~50.915 5μg/m L(r=0.999 9)、29.999 5~299.995 2μg/m L(r=0.999 9);精密度、稳定性、重复性试验的RSD2.0%;加样回收率分别为97.90%~100.68%(RSD=0.95%,n=9)、97.09%~101.85%(RSD=1.32%,n=9)。6个厂家样品中枸橼酸喷托维林的平均累积溶出度分别为12%、98%、66%、97%、91%、32%(n=3),愈创甘油醚分别为8%、95%、68%、90%、93%、18%(n=3)。结论:该方法简便、准确、灵敏度高、专属性强,适于愈酚维林片的溶出度测定;不同厂家样品及同一厂家同批次样品间的溶出度均存在较大差异。
[Abstract]:Objective: to establish a method for determination of dissolution of guaipheneverine tablets and compare the differences of different preparations. Methods: the slurry method was used for dissolution, and water was used as the dissolution medium. The volume is 1 000 mL, the rotational speed is 75 r / min and the sampling time is 45 min. The dissolution of citrate and guaiacol ethers in the preparation is determined by HPLC. The chromatographic column is CAPCELL PAK Cn18MG-II S-5, and the mobile phase is acetonitrile-triphosphate. Ethylamine buffer solution (H 2.6 卤0.05) 33: 67 V / V, flow rate 1.0 mL / min, detection wavelength 215 nm (guaiacylglycerol ethers) 275 nm (guaiacol ether), column temperature 35 鈩，

本文编号：2035542