Study On Quality Analysis Of Levamlodipine Besylate Tablets

To provide the technical support for the quality control of L-amlodipine besylate tablets in production, operation and use, we analyzed the quality status of levamlodipine besylate tablets tested by the National Evaluation Program comprehensively through the national statutory testing standards and exploratory research, and found out the problems in the quality standard. Mean while we want to find the problems in the APIs, accessory, manufacturing technique, packing materials and all these influencing factors’ s relationship.I made examinations according to the legal standards and made ferther stdies and analysis on the results.(1)Combined with the legal inspection results, I made the literature search, enterprise research and risk point analysis;(2)To establish the LC-MS/MS and HPLC method for the determination of related substances and to determine the relationship between the production process and the related substances, 132 batches were tested to study the relationship among the water activity, environmental temperature, humidity and amlodipine lactose adduct impurities.(3) Tests of light, high temperature, high humidity and other factors, dissolution curve consistency evaluation, right-isomer study, L-amlodipine stereospecific identification, raw material crystal form, near-infrared mode were explored and evaluated by LC-MS/MS, HPLC, TLC, IR and X-ray powder diffraction analysis.Results and conclusion:(1)In term of the legal standards, 132 batches were tested and the results were all in conformity with the the regulations. But the results showed that there were 11 standard differences in quality standard including the trait, identification, inspection and content determination, and the setting was not comprehensive and the specificity of the test method was poor. So we need to further unify the existing standards.(2)Comprehensive exploratory study test results found that one manufacturer did not produce according to approved prescriptions and some enterprises prescription process rationality was poor. Production process should adopt the direct pressure process, if the wet granulation process should control the material drying temperature. Packaging should choose shading, good barrier properties of materials. The drug should be saved in a cool place. The amount of dextrorotatory of 105 batches of 11 manufacturers is less than 1.5% limit. And 105 batches of L-amlodipine stereospecific identification are in line with regulations.(3)The IR spectrum and X-ray powder diffraction analysis showed that the crystal forms of the raw materials were the same. 10 consistency test models and 2 correlation coefficient models were established. It was found that there was a significant difference between the addition of lactose and the absence of lactose in the prescription, suggesting that the NIR spectrum could be used to monitor the change of prescription process. Comprehensively, the overall quality of L-amlodipine besylate tablets was evaluated as "good". The legal standard was "basically practicable".In order to make comprehensive analysis and make sure the safe of Levamlodipine besylate tablets, we studied in the process, the scientific and reasonable standards and other aspects of the standards. We proposed to solve the probles and finally improve the quality of products, which ensure the safety of our people.