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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900mL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233nm。结果依替膦酸二钠在浓度16.5～55.0μg·mL-1内线性关系良好(r=0.9995),平均回收率为101.1%,RSD为0.8%(n=9),30min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。
Objective To establish a method for the determination of etidronate disodium tablets dissolution. Methods The spinning basket method was used, in which 900 mL of water was used as the dissolution medium and 0.07% of copper sulfate solution was added to the filtrate. The concentration was determined by UV spectrophotometry with a wavelength of 233 nm. Results The etidronate disodium had a good linear relationship (r = 0.9995) at a concentration of 16.5-55.0 μg · mL-1 with an average recovery of 101.1% and a RSD of 0.8% (n = 9) 90%. Conclusion This method is accurate and simple and can be used to determine the elution of etidronate disodium tablets.