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Detection method of trimethylacetic acid in ampicillin and/or ampicillin sodium

A technology of ampicillin sodium and detection method is applied in the detection field of pivalic acid in ampicillin and/or ampicillin sodium, and achieves the effects of strong specificity, high theoretical plate number and high extraction recovery rate

Active Publication Date: 2019-03-19
CHENGDU BRILLIANT PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The determination method of residual pivalic acid in ampicillin has not been reported in the literature at home and abroad

Method used

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  • Detection method of trimethylacetic acid in ampicillin and/or ampicillin sodium
  • Detection method of trimethylacetic acid in ampicillin and/or ampicillin sodium
  • Detection method of trimethylacetic acid in ampicillin and/or ampicillin sodium

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Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0037] 1. Instruments and equipment

[0038] equipment name

Brand and model

Gas Chromatograph

Agilent 7890B

Electronic balance

XS205DU

Chromatographic column

Agilent DB-FFAP (30m*0.320mm, 1.00μm)

[0039] 2. Reagents and standards, reference substances

[0040]

[0041] 3. Screening of chromatographic parameters

[0042] 1. Selection of sampling method and chromatographic column

[0043] The boiling point of pivalic acid, the solvent to be tested, is 166°C, and the direct sample injection method is selected for analysis; since pivalic acid is relatively polar, the strongly polar DB-FFAP (30m*0.320mm*1.00μm) used for acid analysis is selected column.

[0044] 2. Screening of sample pretreatment methods

[0045] 2.1 Direct dissolution injection analysis

[0046] According to the solubility of APC-SM1, only DMSO can dissolve the test sample in conventional organic solvents, so DMSO is selected as the diluent; considering ...

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Abstract

The invention discloses a detection method of remaining trimethylacetic acid in ampicillin and / or ampicillin sodium. A sample to be detected is detected by a gas chromatographic method, nature or quantity is determined according to chromatographic results, chromatographic conditions include that a chromatographic column is a capillary chromatographic column taking nitroterephthalic acid modified polyethylene glycol as stationary liquid or a chromatographic column with similar or same polarity, a detector is an FID (flame ionization detector), column temperature increase procedures include thatinitial temperature is 60 DEG C and increased to 180 DEG C at the rate of 20 DEG C / min, and the temperature is kept for 5 minutes, increased to 200 DEG C at the rate of 20 DEG C / min and kept for 3 minutes. The detection method is simple to operate, strong in specificity, good in peak shape, high in sensitivity, good in accuracy and repeatability, the results are reliable, the trimethylacetic acidcan be rapidly analyzed, impurities in the technical process can be monitored, and the control requirement of the impurities in finished products can be met.

Description

technical field [0001] The invention relates to the field of detection of impurities in ampicillin and / or ampicillin sodium, in particular to a detection method for pivalic acid in ampicillin and / or ampicillin sodium. Background technique [0002] Ampicillin sodium belongs to the penicillin class of antibiotics and can be used for intramuscular or intravenous injection. It is mainly used to treat upper and lower respiratory tract infections, gastrointestinal tract infections, urinary tract infections, skin and soft tissue infections, meningitis, sepsis, endocarditis, etc. caused by sensitive bacteria. [0003] Ampicillin is an important starting material of ampicillin sodium. According to the production process of ampicillin, there may be a small amount of pivalic acid residue in ampicillin. In order to ensure the safety and effectiveness of ampicillin sodium, it is necessary to detect the residual pivalic acid in the starting material ampicillin. There is no domestic and ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 陈礼莉吕清慧马惠玲
Owner CHENGDU BRILLIANT PHARMA CO LTD
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