盐酸胍法辛缓释片含胍法辛量和释放度测定方法研究

Study on determination method of guanfacine content and releasing rate of Guanfacine Hydrochloride Sustained Release Tablets

目的建立盐酸胍法辛缓释片含胍法辛量和释放度测定方法。方法采用高效液相色谱法,以十八烷基硅烷键合硅胶为填充剂,以磷酸盐缓冲液∶乙腈(48∶52)为流动相;在220 nm波长处检测,用外标法计算盐酸胍法辛缓释片含胍法辛量;释放度以桨法装置,以p H2.2盐酸盐缓冲液900 m L为释放介质,1、3、6、12 h时分别取样,照含量测定的色谱条件测定,用外标法计算各时间点释放量。结果样品在释放介质中和含量测定溶剂中的精密度、线性和回收率均较好。结论该法适于测定盐酸胍法辛缓释片含胍法辛量和释放度。

Objective To establish a method for determining the guanfacine content and releasing rate of Guanfacine Hydrochloride Sustained Release Tablets. Methods The high performance liquid chromatography（HPLC） was adopted with octadecylsilane bonded silica gel as a filler. The mobile phase was phosphate buffer-acetonitrile（48∶52）;the detection was at the wavelength of 220 nm. The guanfacine content of Guanfacine Hydrochloride Sustained Release Tablets was calculated by using the external standard method;the releasing rate was detected by the paddle method. With 900 m L of p H2.2 hydrochloride buffer as the release medium,the samples were taken at 1,3,6,12 h,the detection was performed according to the chromatographic condition of content determination. The external standard method was used to calculate the release time at each releasing point.Results The precision,linearity and recovery rate of the detected solution in the release medium and the content determination solvent were all good. Conclusion The method is suitable for determining the guanfacine content and releasing rate of Guanfacine Hydrochloride Sustained-Release Tablets