普卢利沙星片的质量标准研究

采用高效液相色谱法(HPLC)测定普卢利沙星片中普卢利沙星的含量及有关物质。使用紫外-可见分光光度法测量片剂溶出度,作为普卢利沙星片的质量控制标准的一种新方法。在片剂的含量测定中,3种浓度下回收率均良好,RSD=0.015%,空白辅料对主药测定无干扰。本品3批有关物质均小于1.0%;溶液浓度在(1～10)g/mL范围内,与吸光度值线性关系良好,A=0.097 8C+0.002,相关系数r=1。本品在45 min内溶出量达85%以上。建立的普卢利沙星片的含量、有关物质和溶出度测定方法简便、快速、准确。

Quality Research of Prulifloxacin Tablets

To establish the quality standard for Prulifloxacin tablets.Methods: Utilizing high performance liquid chromatography(HPLC) to determine the content of Prulifloxacin and the relevant components in tablets.The measurement method of dissolution rate is UV-Vis spectrophotometry method.Results: In the content measurement,tablets of three concentrations all have good recovery rates,RSD=0.015%,blank materials have no impact on the determination of medicine.The relevant materials in 3 batches of the tablets were less than 1.0%.The concentration of the solution is in good linear with the absorbance value.In the range of 1~10 g/ml,the linear equation is A=0.097 8C+0.002,the correlation coefficient r=1.In 45 min,this product dissolves more than 85% of the initial amount.Conclusion: The essay method and dissolution determination method are simple,quick and accurate.It could be applicable in quality control.