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目的研究磷酸咯萘啶在不同pH溶剂中紫外吸收特征变化,对药典采用的紫外分光光度法测定磷酸咯萘啶肠溶片含量的方法作了改进。方法以pH2的盐酸溶液作为溶剂,274nm处为测定波长。与用其他溶液作溶剂的方法相比,以优化测定条件。结果在0.5~20mg/L浓度范围内,浓度与吸光度成线性相关,回归方程为A=0.0045+0.0504c,r=0.9998(n=6),天内精密度RSD为0.15%,天间精密度RSD为0.60%,平均回收率为96%以上。制剂辅料无干扰。结论本法与用水或pH7的磷酸缓冲液为溶剂的方法相比,具测定数据稳定,吸收系数大等优点。适用于磷酸咯萘啶肠溶片、注射剂及溶出度等测定。
OBJECTIVE To study the change of UV absorption characteristics of pyronaridine phosphate in different pH solvents and to improve the method of determination of pyronaridine enteric-coated tablets by UV spectrophotometry. Methods pH2 hydrochloric acid solution as a solvent, 274nm at the determination wavelength. Compared with the method of using other solution as a solvent, to optimize the assay conditions. Results In the range of 0.5 ~ 20mg / L, the concentration was linearly related to the absorbance. The regression equation was A = 0.0045 + 0.0504c, r = 0.9998 (n = 6) %, The inter-day precision RSD 0.60%, the average recovery rate of 96% or more. Preparation of accessories without interference. Conclusion Compared with the method of using water or pH7 phosphate buffer as solvent, this method has the advantages of stable measurement data and large absorption coefficient. For pyronaridine phosphate enteric-coated tablets, injection and dissolution determination.