异福片溶出度测定方法的研究

目的:建立异福片溶出度测定方法.方法:采用转篮法,以盐酸溶液(9-1000)为溶剂,转速为100r.min-1,30min时取样.以高效液相色谱法,C18柱(3.8mm×300mm,10um)为固定相,以水-磷酸盐缓冲液-甲醇(850:100:50)为流动相,测定异烟肼的溶出度,检测波长为254nm,流速为1.5mL.min-1.结果:异烟肼在0.3245-1.333 5mg.L(-1)的浓度范围内,线性关系良好.线性方程为:A =56 475C+149.7(r=1.0000);测定异烟肼平均回收率为99.7%(RSD% =0.51%,n=12).结论:增加异烟肼溶出度检查项极为必要.本方法操作简便,结果正确,为完善异福片的质量标准提供有效手段.

Study on Determination Method of Dissolution of Rifampin and Isoniazid Tablets

Objective ： To establish the method for determination of dissolution of Rifampin and Isoniazid Tablets. Method ： The apparatus was used with hydrochloric acid （9→1000） as dissolution medium at a rotate speed of 100 r·min^-1. According to the HPLC method for determined the easd of isoniazid which was dissolved from its tablets in 30 minutes. The dissolution relation were taken and analyzed by HPLC method. A C ls （3.9 mm × 300 mm, 10 t~m） colum was used with a mobile phase consisted of a mixture of water, phosphate buffer solution and methanol （850： 100： 50）. The wavelength used for detection was 254 nm. The flow rate was about 1.5 mL per minute. Results： The linear range of isoniazid 0. 324 5 - 1. 333 5 mg·L^-1 , A =56 475C ＋ 149.7（ r = 1. 000 0）. The satisfactory recoveries were obtained： isoniazid was 99. 7% （RSD% =0. 51% ,n = 12）. Conclusion： It is necessary to set up the method of dissolution of Rifampin and Isoniazid Tablets. The method is rapid, convenient, accurate and reliable. It can be used as a reliable method of quality control for Rifampin and Isoniazid Tablets.