右旋糖酐铁片溶出度测定方法的建立

目的建立右旋糖苷铁片的溶出度测定方法。方法采用《中国药典》2010年版溶出度测定法第三法,以磷酸盐缓冲液（pH 2.0）200mL为溶出介质,转速为100r.min-1,溶出时间为30min。采用比色法测定溶出量,检测波长为476nm。结果本方法在0.5～5μg.mL-1范围内线性良好,r为0.9999;右旋糖酐铁片的平均回收率为98.95%,RSD为1.7%。结论本方法符合溶出度方法的建立原则,操作简单、准确,可控制右旋糖酐铁片的内在质量。

Establishment of dissolution method of Iron dextran tablet

OBJECTIVE To establish a method for the dertermination of the dissolution of Iron Dextran Tablets.METHODS Dissolution method Ⅲ in the Chinese pharmacopoeia 2010 edition was used,dissolution medium was 200mL phosphate buffer solution(pH 2.0),and rotational speed was 100r·min-1.After 30min the dissolution solution was taken and analyzed by ultraviolet-visible spectrophotometric colorimetry at the wavelength of 476nm.RESULTS The linear relationship was in the range of 0.5～5μg·mL-1(r=0.9999),the average recovery was 98.95%(n=9,RSD=1.7%).CONCLUSION The method was consistent with the principle of the determination of dissolution.The operation was simple,accurate and could be used as a method of quality control.