Studies On Quality For Diazepam

The paper systematically studied on quality for Diazepam and its preparations.The method for the test of related substances in diazepam was developed and validated.Structures of three related substances were determined.This paper also did a series of work in the key link of quality control of the solid and liquid preparations .The whole work provided reference for the reinforcement of the National Drug Standard,as well as for the quality-evaluation and the quality-control in the processing of diazepam.The paper consisted of three parts:First, study on the main methods for quality control of API(Active Pharmaceutical Ingredient),as well as the reference substances of the impurities.Established an RP-HPLC method for the analysis of related substances in diazepam.The validation result showed that this method was convenient,sensitive,and had a good specificity.Subsequently,we analyzed the crude products and decomposable compounds of diazepam by LC-MS,determined three related substances,prepared them by rational synthesis and determined their molecular structures by UV,IR,MS,NMR.Then,the purities of these related substances were calculated and the response factors were also determined for the selection of the quantative methods of these related substances.Second,study on the dissolution property of diazepam tablets. Developed a new method for dissolution test,carried out the tests in four mediums with different pH values,and evaluated the dissolution properties of the tablets produced by different factories by f2 factor. The results indicated that a small variation existed in the dissolution properties of these tablets,but also showed that the method in Ch.p could not reflect the dissolution differences.The study provided suggestion and reference for the dissolution method revision and evaluation for the dissolution of solid preparations.Third,study on preservative in liquid preparation.Set up and validated the determination method for benzyl alcohol,which acted as preservative in diazepam injection.Discussed the rationality and scientificalness of the prescription.The study provided reference for the necessity to incorporate the control of inactive components of liquid preparations into the National Drug Standard.