Method for determining related substances in mecobalamin tablet

Abstract

The invention provides a method for determining related substances in mecobalamine. The method comprises the following steps: S1, preparing a mobile phase: respectively preparing a monopotassium phosphate solution, a mobile phase A solution and a mobile phase B solution; S2, preparing a test solution; S3, preparing reference substance stock solutions: respectively preparing a hydroxycobalamin stock solution, a vitamin B12 stock solution and a mecobalamin stock solution; S4, preparing a reference substance solution; S5, preparing an auxiliary material solution; S6, preparing a sensitivity solution; S7, preparing a system applicable solution; S8, chromatographic analysis and determination: analyzing and determining the impurity content of the mecobalamin tablet according to a liquid chromatogram; the method is higher in specificity, and the impurity limit of the mecobalamin tablet is controlled, so that the product quality is more effectively controlled, and a certain basis is provided for research on related substances.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a new method for determining related substances in methylcobalamin tablets. Background technique [0002] Methylcobalamin is an endogenous vitamin B12, which exists in blood and spinal fluid. Compared with vitamin B12, it has a good effect on improving the conduction of neurons, and can promote nucleic acid-protein-fat metabolism through methyl conversion reactions. As a coenzyme of methionine synthase, it can convert homocysteine ​​into methionine, participate in the process of deoxynucleoside synthesis of thymine, promote nucleic acid and protein synthesis, promote axonal transport and axonal regeneration and The formation of myelin sheaths prevents axonal degeneration and repairs damaged nerve tissue. Methylcobalamin tablets have a good therapeutic effect on peripheral neuropathy and have high clinical value. [0003] Due to the instability of its own chemical properti...

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Problems solved by technology

At present, the detection method for related substances in methylcobalamin tablets in the Chinese Pharmacopoeia is relatively simple, and the control of single impurity ≤ 1.0%, total impurity ≤ 3.0%, the single impurity limit is relatively broad, and there is no limit control for known impurities hydroxocobalamin and vitamin B12 , so there are certain hidden dangers in product quality control

[0004] Chinese invention patent CN104122363A discloses a kind of assay method of related substances of methylcobalamin tablets, comprising the following steps: 1. preparation of test product: 2. preparation of reference substance; : The stationary phase is a chromatographic column filled with octadecylsilane bonded silica gel, the mobile phase is a mixture of acetonitrile and phosphate buffer; the detection wavelength is 300-360nm, the injection volume is 20μl, and the column temperature is 30°C, flow rate 0.5-1.5ml / min; gradient elution; ④ Calculate the content of each impurity in the test sample. Although this method controls the single impurity content ≤ 1.0% and the total impurity content ≤ 2.0%, the single impurity The limit is relatively broad, and there is no limit control on RRT content of about 1.09, RRT content of about 1.20 and hydroxocobalamin content, so there are still certain hidden dangers to product quality control

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