Quality standard of dexamethasone sodium phosphate injection and detection method thereof

Abstract

The invention provides a quality standard detection method of a dexamethasone sodium phosphate injection. The quality standard detection method comprises the steps of: preparing a reference substancesolution, namely, weighing a nicotinamide reference substance, and adding water to dissolve the nicotinamide reference substance to prepare a nicotinamide reference substance solution; preparing a test sample solution, namely, measuring the dexamethasone sodium phosphate injection to be detected, and adding water to dissolve the dexamethasone sodium phosphate injection to prepare a nicotinamide test sample solution; preparing a system suitability solution, namely, measuring the dexamethasone sodium phosphate injection, and adding water to dilute the dexamethasone sodium phosphate injection toprepare a solution A; weighing a nicotinic acid reference substance, and adding water to dissolve the nicotinic acid reference substance to prepare a solution B; respectively measuring the solution Aand the solution B, and adding water to dilute the solution A and the solution B, so as to prepare a mixed solution containing nicotinic acid and nicotinamide; and injecting the prepared mixed solution into a liquid chromatograph for detection, respectively weighing the nicotinamide reference substance solution and the nicotinamide test sample solution and injecting them into the liquid chromatograph for detection if a separation degree of nicotinamide and nicotinic acid is not less than 3.0 and a number of theoretical plates calculated according to nicotinamide is not less than 2000, so as toobtain content of nicotinamide in the nicotinamide test sample solution.

Description

technical field [0001] The invention relates to the technical field of chemical drug injections, in particular to a quality standard for dexamethasone sodium phosphate injection and a detection method thereof. Background technique [0002] Dexamethasone sodium phosphate belongs to glucocorticoid drugs. It is white or slightly yellow powder, odorless, slightly bitter, easy to absorb moisture, easily soluble in water, and insoluble in chloroform, ether, and acetone. Dexamethasone Sodium Phosphate Injection is an injection, which is a common drug, and it is a white clear solution. It is mainly used for the treatment of allergic and autoimmune inflammatory diseases, and is mostly used for connective tissue diseases, active rheumatism, and rheumatoid joints. Inflammation, lupus erythematosus, severe bronchial asthma, severe dermatitis, ulcerative colitis, acute leukemia, etc. It is also used in the comprehensive treatment of certain severe infections, poisoning, and malignant lym...

AI Technical Summary

Problems solved by technology

The amount of nicotinamide added in dexamethasone sodium phosphate injection is about three times that of the main component dexamethasone sodium phosphate, but the original quality standard only measures the content of dexamethasone sodium phosphate in the injection, and the content of dexamethasone sodium phosphate Sodium content is not a good indicator of product quality

Images