Establishment And Verification Of Puri - Bahrain Standard And Test Method

The thesis is for testing company new product Pregabalin, which develop analytical method and validate the method, then establish Pregabalin routine release test method and in-house specification. The thesis is divided into four chapters, the major content is:The first chapter introduce background of select the title and purpose, which describe testing and validate the method of Pregabalin assay and Pregabalin R-isomer content, literature review, introduce characteristic of Pregabalin, problem of Pregabalin R-isomer test, and choose Nα-(5-fluoro-2,4-dinitrophenyl)-L-alanine amide (FDAA) as derivatization reagents to test Pregabalin R-isomer.The second chapter research HPLC method and validate the method for test Pregabalin R-isomer, which introduce the principle of Nα-(5-fluoro-2,4-dinitrophenyl)-L-alanine amide (FDAA) as derivatization reagents to test Pregabalin R-isomer and choose derivatization regent, mobile phase, detrivatization reaction reagent and catalyst, column, wavelength of detector, volume of derivatizaition reagent and derivatization reation time and temperature. And prove the test is sensitive, accurate, reliable from specificity, linearity, range, accuracy, LOQ, LOD, precision and robustness.The third chapter research HPLC method and validate the method for test Pregabalin assay, which introduce to choose column, wavelength of detector, and the problem of tesing. And prove the test is sensitive, accurate, reliable from specificity, linearity, range, accuracy, precision and robustness.Appendix chapter based on validated HPLC method and industrial international regulatory, establish Pregabalin specification and test method with other physical chemical analysis.Finally, summarize the application of the method and prospect of an extension of its future value. The research combine characteristic of Pregabalin and chromatographic study together, prove the test methods have good direction, and easy, fast, sensitive, accurate, reliable. The established Pregabalin specification and test method will be used to test Pregabalin product in the future, and have a pivotal role in controlling the quality of Pregabalin product.