Study On Quality Of Compound Felodipine Sustained-release Tablets

Isosulfan as a new type of lymphatic tracer,has very good effect to the lymphatic positioning,fast dyeing and durable,can obviously improve the accuracy and sensitivity of Sentinel lymph node biopsy(SLNB)using dye type alone,in the treatment of cancer has a wide range of applications.At present Isosulfan is not listed in our country,is the original manufacturer COVIDINE company,different sulfur blue are FDA approved the first and only one for lymphatic tracer dye,has been in clinical use for many years,many studies have shown that different sulfur blue has a great value in clinic.In continuous intraoperative lymphatic leakage treatment,different sulfur blue can be used to identify and help ligation lymph vessels.Reference a large number of literatures,this paper designed Isosulfan synthetic route is 2-chlorobenzene formaldehyde-5-sodium sulfonate as the starting material,by two step sulfonation,condensation,cyclization and reduction reaction was prepared by Isosulfan,high performance liquid detection purity is greater than 99.3%,the total yield of 40.76%.The synthesis route is shorter,the craft is simple,easy to operation.We use homemade Isosulfan to establish its quality standard and the standard of API methodology validation,using high performance liquid chromatography(HPLC)method and verify content including accuracy,linearity,precision,and loq,durability,system suitability.According to the results can satisfy the requirements of the method validation under the standard.Using high performance liquid chromatograph method of high sensitivity,strong specificity,the result accurate,suitable for Isosulfan determination of blue and active pharmaceutical ingredients.