琥珀酸去甲文拉法辛缓释片的质量检测

Quality control of desvenlafaxine succinate extended-release tablets

目的建立琥珀酸去甲文拉法辛缓释片释放度、含量、含量均匀度及有关物质检测方法,并进行方法学验证。方法采用紫外分光光度法测定释放度,高效液相色谱法测定含量、含量均匀度及有关物质,分别考察专属性、线性、回收率、精密度及稳定性等,进行方法学验证。结果释放度方法学验证结果显示,该方法专属性好,在10~200μg/ml范围内线性关系良好,回收率、重复性及中间精密度均符合要求;含量、含量均匀度检测方法验证结果显示,该方法专属性良好,在5~400μg/ml范围内线性关系良好,回收率、重复性及中间精密度均符合要求,溶液在24 h内稳定;有关物质方法学验证结果显示,该方法专属性好,灵敏度高,线性、回收率均符合要求,且溶液在室温条件下放置24 h稳定性良好。结论释放度检测方法简单、灵敏、专属性好、准确度高,含量及含量均匀度检测方法准确可靠,有关物质检测方法准属性好、灵敏度高,均可用于琥珀酸去甲文拉法辛缓释片的质量控制。

Objective To establish and validate the assay methods of release,content,content uniformity and related substances of desvenlafaxine succinate（DVS）in extended- release tablets. Methods The ultraviolet spectrophotometric method was used to determine the DVS release from DVS extended-release tablets. The content uniformity,content and related substance were determined by high-performance liquid chromatography（HPLC）. To validate all the method,we respectively examined specificity,linearity,recovery rate,precision and stability,etc. Results The results showed that the analysis method for release was specific,the calibration curve was linear in the range of 10-200 μg/ml,and all the recovery,repeatability and intermediate precision met requirements.The method for detection of content and content uniformity was specific and linear in the range of 5-400 μg/ml,the recovery,repeatability and intermediate precision met requirements. The method for related substances was specific and sensitive,the linear and recovery rate met the requirements. All of the solutions were stable during 24 h at room temperature. Conclusion The analysis method for release is simple,sensitive,specific and accurate,the method for content and content uniformity is accurate and reliable,and the method for related substances is specific,sensitive and accurate. These methods are suitable for quality control of DVS extendedrelease tablets.