Determination Of Residual Solvents And Analysis Of Impurities In Simvastatin

The safety of synthetic drugs is closely related to the people’s life and health.The residual solvents in drugs are volatile organic chemicals produced in the control of drug production or in the process of process control,and are not easy to remove.The content of residual solvents not only directly affects the quality of medicines,but also the safety of the people.Therefore,it is of great significance to investigate and test the residual solvents in pharmaceuticals and the content of related substances.In accordance with the actual production situation of Tian Fang pharmaceutical industry,in accordance with the requirements of the 9 edition of European Pharmacopoeia and the requirements of India Biocon company,the method of testing the residual solvents of simvastatin was established and verified in the laboratory.The related material analysis and stability were studied according to the requirements of ICH;the newly established simvastatin detection method system was used in production.Process optimization is carried out in the process.The results of this study are as follows:(1)Established a detection system for residual solvents in simvastatin.The result of the specificity test shows that the baseline separation degree of each test component is high and that there is no interference with each other.The test results show that the measured components have a lower limit of quantity,which is far below the limit requirement and can meet the requirements of the detection.The linear experimental results show that the test results and the concentration of the analyte in the given range show that the results are in the given range.The results of the precision test show that the results of the same homogeneous sample are very close to the results of multiple sampling,and the precision of the measured components is high and the reproducibility is good,and the results of accuracy test show that,The recovery rate of the ingredients to be measured is above 80%,and the relative standard deviation of the recovery rate is less than 10%.In the durability test,the minimum separation degree of each component is more than 1.5% under the conditions of different temperature and flow rate,which is in line with the requirements.(2)The method system is applied to the detection of residual solvents and related substances after the optimization of the laboratory process.The results show that the quality of the products after the optimized process meets the relevant quality standards.(3)Through the analysis of impurities and stability of three batch samples of large scale production,the results show that the production process of simvastatin has a high reproducibility in the existing production site.(4)The product quality conforms to the requirements of the European Pharmacopoeia and the India Biocon company due to the reduction of residual solvents and the reduction of related substances through the application of the detection method established in this paper to the new synthesis process.The establishment and validation of the testing methods ensure that enterprises can produce large quantities of simvastatin products that meet quality requirements on a continuous and stable scale.