衍生化紫外分光光度法测定依替膦酸二钠片的溶出度

Determination of Dissolution in Etidronate Disodium Tablets by Derivatization with UV Spectrophotometry

摘要: 目的建立测定依替膦酸二钠片溶出度的方法。方法采用转篮法，以水900 mL为溶出介质，于续滤液中加0.07%硫酸铜溶液，用紫外分光光度法测定，波长为233 nm。结果依替膦酸二钠在浓度16.5～55.0 μg·mL^-1内线性关系良好(r=0.999 5)，平均回收率为101.1%，RSD为0.8%(n=9)，30 min时平均溶出量大于90%。结论本法准确，简便，可用于测定依替膦酸二钠片的溶出度。

Abstract: OBJECTIVE To establish a method for the determination of dissolution in etidronate disodium tablets. METHODS Perform the dissolution test with baskets, using 900mL of water as the dissolution medium, withdraw a quantity after exact 30 minutes and filter. Transfer 2 mL of the successive filtrate, to a 10 mL volumetric flask, add 2 mL of 0.07% solution of copper sulfate and diluted with water to the volume. Determine the absorbance at 233 nm. RESULTS The calibration curve was linear over the range of 16.5-55.0 μg·mL^-1 for etidronate disodium. The average recovery of etidronate disodium was 101.1% with RSD 0.8% (n=9). The dissolution from each tablet was more than 90% of the labeled amount in 30 minutes. CONCLUSION The established method is accurate, simple, and could be used for the determination of dissolution in etidronate disodium tablets.