雷奈酸锶干混悬剂溶出度方法的建立

目的: 建立雷奈酸锶干混悬剂溶出度测定方法. 方法: 选用318 nm作为检测波长,用分光光度法对雷奈酸锶主成分进行测定.采用桨法考察不同转速(50、75、100 r·min^-1)和不同溶出介质(0.05 mol·L^-1盐酸溶液、pH 4.5醋酸盐缓冲液、pH 6.8磷酸盐缓冲液、水)对雷奈酸锶干混悬剂溶出行为的影响,建立雷奈酸锶干混悬剂的溶出度测定方法.并对所建立方法进行方法学考察. 结果: 分光光度法测定雷奈酸锶方法可行.方法学验证结果表明,溶液在室温条件下放置12 h其RSD仍小于2%,证明溶液在室温下稳定;雷奈酸锶质量浓度在4.425~26.549 μg·mL^-1范围内呈良好的线性;平均回收率98.6%,RSD为1.4%,该方法准确度良好;重复性试验RSD小于10%,证明方法精密度良好.0.05 mol·L^-1盐酸溶液作为溶出介质溶出速度快且较为平缓.利用所建立的溶出度测定方法对2批市售制剂进行测定,30min内2批样品的溶出度分别为98.4%和98.3%. 结论: 所建立的溶出度测定方法经方法学考察,可对雷奈酸锶干混悬剂进行溶出度测定.

Objective: To establish the dissolution method of strontium ranelate for suspension. Methods: With 318 nm as the detection wavelength,the UV spectrophotometry was used to determine strontium ranelate.The paddle method was applied to study the influence of different rotate speeds(50,75,100 r·min^-1)and dissolution mediums(0.05 mol·L^-1 hydrochloric acid solution,pH 4.5 acetate buffer,pH 6.8 phosphate buffer and water)and the dissolution method was established according to the final results.Then the methodology validation of this method was carried out. Results: The determination method of UV spectrophotometry was reliable.As a result,the RSD value of stability was less than 2%,which indicated the solution was stable in 12 h under room temperature.Strontium ranelate had good linearity between 4.425-26.549 μg·mL^-1.The average recovery was 98.64% and the RSD was 1.4%,which indicated good accuracy of this method.The RSD value was less than 10% in repeatability,which indicated good precision.The 0.05 mol·L^-1 hydrochloric acid solution was the most appropriate dissolution medium which owned fast dissolution rate and was relatively smooth.With the current method,two batches of commercial strontium ranelate for suspension were determined.The dissolution rates for the two batches were 98.4% and 98.3% after 30 min,respectively. Conclusion: With the methodology validation,the method established could be used to determine the dissolution rate of strontium ranelate for suspension.