RESUMEN
Objective To establish and validate the assay methods of release,content,content uniformity and related sub?stances 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 deter?mined 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 calibra?tion curve was linear in the range of 10-200μg/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 5-400μg/ml,the recovery,repeat?ability 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 meth?od 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 extended-release tablets.
RESUMEN
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.