Hydrochloric Acid Trimetazidine Check On The Quality Of Study Material

Drugs and pharmaceuticals research and development in the evaluation process, impurities Study is a very important element. Because of impurities research and the quality and safety of medicines directly related to effectiveness, in order to enhance the quality of drugs, the medication to protect public safety, and so in the process of developing drugs to regulate conduct impurity studies, and their control in a safe and reasonable within limits.In impurity analysis method, the application of chromatographic analysis is the most current analytical methods. The high performance liquid chromatography (HPLC) is a very wide range of applications, high performance liquid chromatography as an important analytical method, it has speed, high resolution, high sensitivity, the column can be repeatedly used, the sample volume less easy recovery, and other characteristics. Qualitative analysis of quantitative almost across the various fields.Hydrochloric acid Trimetazidine raw materials, for their agents of trimetazidine Hydrochloride Tablets, a registered chemicals classification 6 (a generic drug). Author import standards X20010229 in light of the material inspection methods (HPLC), and in light of the raw materials in the production of synthetic line, considering the final product may be related substances: trimethoxybenzaldehyde formaldehyde, piperazine. While its related impurities trimethoxybenzaldehyde formaldehyde, piperazine carry out the inspection of material, using high-performance liquid chromatography analysis of inspection.The main purpose of this paper is to establish an effective hydrochloride Trimetazidine raw materials analysis of the material inspection methods. Blank solvent through interference tests, the number of theoretical plates, and the detection limit, the limit of quantification, oxidative damage, light damage, alkali damage, acid damage, heat damage, and other tests, and trimethoxybenzaldehyde formaldehyde, piperazine hydrochloride Trimetazidine and the mixture of three kinds of material analysis, trimethoxybenzaldehyde formaldehyde, piperazine hydrochloride with the main peak of trimetazidine reached baseline separation of the main peak and the adjacent peak separation of impurities have to comply with the requirements to achieve a complete separation, this means that the exclusivity better, chromatographic conditions can accurately control its volume of the material, it may be the practical application of the Act, the ultimate realization of trimetazidine hydrochloride quality controlled, safe and effective purpose.