Study On The Quality Of Dasatinib

Dasatinib(trade name Sprycel)is a new generation of tyrosine kinase inhibitors developed by Bristol-Myers Squibb Company.The product has been marketed abroad but not yet sold on the domestic pharmaceutical market,and there are not any standards for quality control.The purpose of this paper is to establish a set of scientific and perfect analysis methods to control the quality of Dasatinib(including bulk drug and tablets),and stability tests were studied.The main contents include:(1)Physicochemical properties of Dasatinib bulk drug had been determined;the instrumental analysis method was adopted for identification of bulk drug;residue on ignition,chloride,heavy metals and other items had been examined.The HPLC methods were established for determining the content and related substances of Dasatinib;The GC method was established for determining the residual solvents.Validation tests were done for all methods.The results shown that HPLC and GC method had good specificity,high sensitivity,and good reproducibility,and could be used for the quality control of Dasatinib bulk drug.(2)The instrumental analysis methods(UV and HPLC)were adopted for identification of Dasatinib tablets.The HPLC methods were established to determine the content,content uniformity,dissolution and related substances of the Dasatinib tablets,and the established methods were validated.The results shown that the established method had good specificity and high sensitivity,thus they were very useful for the quality control of Dasatinib tablets.(3)According to the requirements of the ICH guidelines,stability tests were carried out for different batches of Dasatinib bulk drug and tablets containing influencing factors test,accelerated test and long-term test.The results shown that each project all has no obvious change,and the indicators conform to the requirements of the quality standard.