A kind of assay method of related substance of methylcobalamin tablet

Abstract

The invention provides a measuring method of mecobalamin tablet related substance. The measuring method comprises the steps of (1) preparing a test sample; (2) preparing reference substance; (3) measuring the content of the related substance by high performance liquid chromatography, wherein the chromatographic conditions are as follows: stationary phase is a chromatographic column taking octadecyl silane bonded silica gel as filler, mobile phase is mixed solution formed by acetonitrile and phosphate buffer solution, the detection wave length is 300-360nm, the sample amount is 20mu l, the column temperature is 30 DEG C, and the flow velocity is 0.5-1.5ml / min; gradient elution is carried out; and (4) calculating the content of all impurities in the test sample. The measuring method of the mecobalamin tablet related substance is high in universality, good in reproducibility, high in degree of separation and accurate in detection result; the methodology validation proves that the measuring method has a stable indicative function, and is capable of rapidly and accurately controlling the limit of all the impurities in mecobalamin tablets, so that the quality can be controlled; furthermore, the measuring method is low in cost, and has good economic benefit and popularization prospect.

Description

technical field [0001] The invention relates to the technical field of analytical chemistry, in particular to a method for determining related substances of methylcobalamin tablets. Background technique [0002] Methylcobalamin, also known as methyl vitamin B12, is a dark red crystal or crystalline powder; odorless, tasteless; strong hygroscopicity; easy to decompose when exposed to light; the molecular formula of methylcobalamin is C 63 h 91 C O N 13 o 14 P, the molecular weight is 1344.38, its structure is a macrocyclic complex centered on cobalt ion, the structural formula is as follows: [0003] [0004] Methylcobalamin is the effective active ingredient of methylcobalamin tablets, and it is a derivative of vitamin B12 (cyanocobalamin). It can be known from the above structural formula that because a methyl group is combined on the central cobalt molecule, it participates in the methyl group of the substance. Conversion and nucleic acid, protein and fat metabolis...

AI Technical Summary

Problems solved by technology

The shortcomings of this detection method are: ①Since methylcobalamin tablets are coated tablets, this detection method is more sensitive to the excipients of the tablet, if the coating is not completely removed, it will interfere with the detection results of related substances; ②Because The tablet is small in size, so it is difficult to remove the coating, and there is one more process, which is cumbersome; ③Under the condition of dark, there are factors that the coating is not clean, which will affect the accuracy of the detection; ④The excipient peak and the impurity peak have different Overlapping, poor resolution, and interference in integration; ⑤ Practice has proved that the same detection method uses different instruments, and the separation effect of each impurity is different, indicating that the detection results obtained by this detection method have poor reproducibility and do not have a stability indicator

[0009] In summary, the existing detection methods for related substances in methylcobalamin tablets mainly have technical defects such as cumbersome detection steps, low detection sensitivity, poor separation between excipient peaks and impurity peaks, and poor reproducibility of detection results.

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