Study on Quality and Stability of Landiolol Hydrochloride
|Keywords||Of landiolol hydrochloride Quality standards Quality Research Stability of|
Of landiolol hydrochloride is listed for surgery for the first time in Japan in September 2002 by Japan Ono Ono Pharmaceutical Industry Co., Ltd. was first developed tachycardia, arrhythmias (including atrial fibrillation, atrial flutter, sinus tachycardia) emergency treatment. In October 2006 in the indications for additional surgery after cycle dynamic monitoring tachyarrhythmias (including atrial fibrillation, atrial Coarse approved the emergency treatment of sinus tachycardia), registered . In order to meet the needs of the varieties of domestic clinical Our company has developed a the hydrochloric acid landiolol raw materials and lyophilized preparation. This thesis is based on literature research, according to the modern study of the situation and the molecular structure of the product features, the inspection of the of hydrochloric acid landiolol quality research methods, the use of modern analytical techniques such as high performance liquid chromatography to determine the appropriate testing conditions, the preparation and drafting of a scientific and rational quality standards, and its stability was investigated to provide test data to control the quality of the product as well as the development of quality standards. Hydrochloride landiolol quality of this paper, appearance, solubility, cited moist, melting point, Specific rotation investigated of hydrochloric acid landiolol raw materials traits. Chemical identification method, UV spectrophotometry, high performance liquid chromatography, Fourier transform infrared spectroscopy, and differential response of chloride were identified. This product is injection with raw materials, according to the chemical nature of the goods and the preparation process to determine related substances, acidity, clarity and color of the solution, loss on drying, heavy metals, residue on ignition and the solvent used in the synthesis of residual checks, different isomer as the product of the inspection items. Molecular structure affect of the product as well as the synthesis process is characterized by the material become the focus of the study of the quality of this product, using high performance liquid chromatography method for the determination of the species related substances, method validation to determine the appropriate chromatographic conditions; Because this product molecules structure containing two chiral carbon, there are four isomers, isomer may be difficult to split, CHIRAL-CBH column (5μm, 150mm × 4.0mm) Method Study results show that, taking into account the specificity, reproducibility and sensitivity are in line with the requirements of the determination. According to the \This product is used in the synthesis route of the synthesis process according to the present product, the second hydrocarbon solvent of methanol, n-hexane, the third hydrocarbon solvent of ethanol, dimethylsulfoxide, ethyl acetate, acetone. With reference to the limits of the above guiding principles and provisions of methanol, n-hexane, ethanol, dimethylsulfoxide, ethyl acetate, acetone limits were 0.3%, 0.029%, 0.5%, 0.5%, 0.5% and 0.5%. Solvent residue in the basic raw material is not detected, the internal standard method, can effectively control the solvent residue of raw materials, the performance metrics of the other Law was validated, the results feasible. Studied the method of high performance liquid chromatography hydrochloric acid landiolol content, according to the nature of the goods and the method validation, including linear range, recovery, precision, solution stability, and by potentiometric titration verify the accuracy of the high-performance liquid chromatography. More than the quality of research, in order to control the quality of the product and the development of quality standards of the test data. Hydrochloric acid landiolol quality standards and drafting on the basis of a comprehensive quality research, combined with the actual situation, the development of the scientific and reasonable quality standards, including the character, identification, assay and other projects, there are physical constant melting point and specific spin Determination of the chemical method, UV spectroscopy, HPLC, chloride differential response identification landiolol hydrochloride, HPLC determination of content and related substances, measured by gas chromatography solvent residues, other residue on ignition, heavy metals, loss on drying and so do a careful test. Drafting instructions on project quality standards and indicators reasonable and necessary to do further instructions. 3 of hydrochloric acid landiolol Stability in on the basis of scientific and reasonable quality standards, in accordance with the requirements of the Pharmacopoeia Appendix test the hydrochloride the stability landiolol visits, including the impact factor test, accelerated test and long-term stability test. The results show that the hydrochloric acid landiolol to light more stable compromise in stability, high temperature (60 ° C), humidity instability. The results of this test of landiolol hydrochloride storage conditions provide a basis for making valid, as well as the preparation process and the quality of the preparations of reliable information.