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目的建立叶酸片的溶出度及其含量测定的方法。方法采用紫外-可见分光光度法测定叶酸片的溶出度,同时使用高效液相色谱(HPLC)法测定其含量。结果溶出度:精密度RSD=0.94%,稳定性RSD=0.80%,紫外分光光度回收率为99.85±0.76,溶出量均在75%以上。含量:精密度RSD=0.59%,稳定性RSD=0.53%,重复性RSD=0.66%,准确度RSD=0.91%,HPLC法回收率为99.32±0.87。结论采用紫外-可见分光光度法与HPLC法测定叶酸片的溶出度及其含量简便、准确可靠,可用于控制该制剂的质量。
Objective To establish a method for the determination of the dissolution of folic acid tablets and its content. Methods The dissolution rate of folic acid tablets was determined by UV - Vis spectrophotometry, and its content was determined by high performance liquid chromatography (HPLC). The results of dissolution: precision RSD = 0.94%, stability RSD = 0.80%, UV spectrophotometric recovery of 99.85 ± 0.76, dissolution were more than 75%. Content: precision RSD = 0.59%, stability RSD = 0.53%, repeatability RSD = 0.66%, accuracy RSD = 0.91%, HPLC recovery was 99.32 ± 0.87. Conclusion The dissolution of folic acid tablets by UV-visible spectrophotometry and HPLC method is simple, accurate and reliable, and can be used to control the quality of the preparation.