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HPLC detection method of mecobalamin injection relevant substances

A detection method and related substance technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of ineffective control of injection product quality, low detection method sensitivity, difficult to achieve baseline separation, etc., to achieve enhanced retention time and sensitivity And the effect of high accuracy and fast speed

Active Publication Date: 2019-10-11
HARBIN SANLIAN PHARMA CO LTD
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Problems solved by technology

[0006] Wu Qiongzhu et al. 221-222 pages) discloses a kind of method that HLPC measures the related substances of methylcobalamin, what this method adopts is amino column, sees from the chromatogram disclosed in this document, methylcobalamin and known impurity hydroxocobalamin degree of separation are not high High, especially after destroying the sample, there are many impurities, and many unknown impurities are difficult to achieve baseline separation, and the chromatographic conditions are reverse chromatographic conditions, while amino columns are often used in normal phase chromatographic conditions. Such chromatographic conditions lead to Columns are not durable and easily damaged
[0007] In a word, the known impurities of cyanocobalamin and hydroxocobalamin in different degrees in the existing detection methods of related substances of methylcobalamin injection cannot be effectively separated, Inability to effectively control the product quality of injections, low detection method sensitivity, poor durability and other defects need to be improved

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  • HPLC detection method of mecobalamin injection relevant substances
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  • HPLC detection method of mecobalamin injection relevant substances

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Embodiment 1

[0035] The HPLC detection of the related substance of embodiment 1 methylcobalamin injection

[0036] The chromatographic conditions are: chromatographic column: 4.6mm×250mm, 5μm, using octadecylsilane bonded silica gel as filler, mobile phase:

[0037] Buffered saline solution: acetonitrile (85:15) as mobile phase A; acetonitrile as mobile phase B.

[0038] Buffer salt solution -- 0.02-0.15 mol / L potassium dihydrogen phosphate solution of 0.025 mol / L sodium hexanesulfonate, adjust the pH to 4.0-7.0 with dilute phosphoric acid;

[0039] Flow rate: 1.2~1.5ml / min, column temperature: 30°C; detection wavelength: UV266nm;

[0040] Elution method: gradient elution, the gradient elution program is shown in Table 2.

[0041] Table 2 Gradient elution program

[0042] time (min) Mobile phase A(%) Mobile phase B(%) 0 100 0 5 97 3 10 90 10 30 90 10 35 100 0 40 100 0

[0043] Specific detection method:

[0044]Light-proof operatio...

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Abstract

The invention discloses an HPLC detection method of mecobalamin injection relevant substances. According to the HPLC detection method, a 266nm wavelength is used as a detection wavelength, and therefore impurities can be separated more sufficiently; an ion pair reagent is added into a mobile phase, so that the retention time of an analyte on a chromatographic column is prolonged; an optimized gradient elution procedure is adopted for elution, so that the number of the precipitated impurities is large; and damage tests of acid, alkali, heat, oxygen, light, etc. prove that all known impurities and unknown impurities in the analyte can be thoroughly separated. The HPLC detection method is high in specificity, sensitivity and accuracy and good in durability; and meanwhile, an external standardmethod is adopted to perform limit control on the two known impurities cyanocobalamin and hydroxycobalamin, and therefore the safety, effectiveness and quality controllability of an injection can bebetter ensured.

Description

technical field [0001] The invention relates to a method for detecting related substances in methylcobalamin injection, and belongs to the field of analysis or detection of impurities in methylcobalamin injection. Background technique [0002] Methylcobalamin is a coenzyme-type vitamin. The methylated functional group of methylcobalamin can participate in the methyl transfer in the body, thereby promoting the metabolism of nucleic acid, protein and fat in the nervous tissue in the body. In the metabolism of the human body, methylcobalamin and adenosylcobalamin can directly participate in the metabolism in the body and have a direct therapeutic effect on diseases. Studies have found that methylcobalamin is extremely unstable, especially in aqueous solution conditions, it can be rapidly decomposed into hydroxocobalamin when exposed to light, and many impurities will also be produced during production and storage, such as the known impurities cyanocobalamin and hydroxocobalamin...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/36
CPCG01N30/02G01N30/06G01N30/36G01N2030/047
Inventor 任萃文胡玉庆黄薇薇陆勇葛影佟智慧朱明艳张宇卢立波王萍萍孙维扬姚烁
Owner HARBIN SANLIAN PHARMA CO LTD
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