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Method for detecting residual organic solvent in mecobalamin

A technology for residual organic solvents and methylcobalamin, which is applied in the field of detection of methylcobalamin residual organic solvents, can solve problems such as the detection technology of residual organic solvents of methylcobalamin, and achieve the effect of simple operation and good sensitivity

Active Publication Date: 2014-07-30
NINGXIA KINGVIT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

After searching, it is found that there is no determination technology for the determination of methylcobalamin residual organic solvents

Method used

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  • Method for detecting residual organic solvent in mecobalamin

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Embodiment Construction

[0016] The embodiments of the present invention are described in detail below: the present embodiment is implemented under the premise of the technical solution of the present invention, and detailed implementation methods and specific operating procedures are provided, but the protection scope of the present invention is not limited to the following implementation example.

[0017] Implementation of instruments and reagents:

[0018] HP5890 gas chromatograph, DB-624 capillary column (30m×0.52mmm×3.0μm).

[0019] Acetone, tetrahydrofuran (analytical grade)

[0020] Chromatographic conditions

[0021] The gasification chamber temperature is 180°C, the column temperature is 30°C, the FID detector temperature is 300°C, and the high-purity N 2 Carrier gas, column pre-pressure 4psi, split ratio 100. Solvent DMF, internal standard method, internal standard substance is tetrahydrofuran.

[0022] Detection steps:

[0023] ① Take 0.05g of methylcobalamin test sample, put it in a ...

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Abstract

The invention relates to a method for detecting a residual organic solvent in mecobalamin. The method comprises the following steps of: (1) adding a mecobalamin test sample into a tetrahydrofuran-containing DMF (dimethyl formamide) solution, dissolving to obtain a test sample solution and adding an acetone-containing DMF solution into the tetrahydrofuran-containing DMF solution to obtain a reference substance solution; (2) performing gas chromatography on the reference substance solution, recording a chromatogram (tRm acetone is approximately equal to 2.0min and tRm tetrahydrofuran is approximately equal to 4.8min), measuring the area ratio of the chromatographic peak of acetone to the chromatographic peak of tetrahydrofuran, taking the acetone and the tetrahydrofuran in different ratios and repeatedly measuring for multiple times, recording chromatographic peaks and calculating a regression equation of acetone content according to the area ratio of the chromatographic peak of acetone to the chromatographic peak of tetrahydrofuran by adopting an internal standard method to obtain the regression equation; (3) measuring the precision and the recovery ratio of a mecobalamin test sample solution in sequence according to the steps; and (4) if the area ratio of the chromatographic peak of acetone to the chromatographic peak of tetrahydrofuran in the chromatogram of the test sample solution is less than the area ratio of corresponding chromatographic peaks in a standard substance chromatogram, determining that the content of the acetone in the test sample is less than 5,000 ppm.

Description

technical field [0001] The invention relates to the technical field of organic residue detection, in particular to a method for detecting methylcobalamin residual organic solvents. Background technique [0002] Gas chromatography analysis method is a chromatographic method using gas as the mobile phase. It has the characteristics of wide application range and high separation efficiency. It has been widely used in the determination of residual organic solvents in drugs in recent years. [0003] Methylcobalamin is a chemical raw material used for the treatment of diabetic peripheral neuropathy, and it is combined with other vitamin B 12 In contrast, it has good transferability to nerve tissue. Methylcobalamin can promote nucleic acid-protein-fat metabolism through methyl conversion reaction, accelerate the repair and functional recovery of degenerated or diseased and atrophied nerve tissue, thereby improving sensation and movement. and peripheral nerve function. After search...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/86G01N30/02
Inventor 王义王文超冷晓红王景奇乃
Owner NINGXIA KINGVIT PHARMA
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