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Determination method of pivalic acid in ampicillin and/or ampicillin sodium

A technology of ampicillin sodium and a detection method is applied in the field of detection of pivalic acid in ampicillin and/or ampicillin sodium, and achieves the effects of good reproducibility, rapid analysis, and high number of theoretical plates

Active Publication Date: 2021-09-21
CHENGDU BRILLIANT PHARMA CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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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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  • Determination method of pivalic acid in ampicillin and/or ampicillin sodium
  • Determination method of pivalic acid in ampicillin and/or ampicillin sodium
  • Determination method of pivalic acid in ampicillin and/or ampicillin sodium

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Experimental program
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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 the higher lim...

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Abstract

The invention discloses a method for detecting residual pivalic acid in ampicillin and / or ampicillin sodium. Gas chromatography is used to detect the sample to be inspected, and the chromatographic results are qualitative or quantitative. The chromatographic conditions include: the chromatographic column adopts nitro-p-phenyl Diformic acid-modified polyethylene glycol is a capillary chromatographic column with fixed liquid or a chromatographic column with similar or equal polarity, and the detector adopts FID detector; The rate was increased to 180°C for 5 minutes, and then increased to 200°C at a rate of 20°C / min, and maintained for 3 minutes. The detection method of the present invention is simple in operation, strong in specificity, good in peak shape, high in sensitivity, good in accuracy and reproducibility, reliable in results, can realize rapid analysis of pivalic acid, and can meet the requirements of impurity monitoring in the process and monitoring of finished products. Impurity control requirements.

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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Patent Type & Authority Patents(China)
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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