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Detection method of residual solvent 4-methyl-2-pentanone in tiamulin fumarate

A technology for tiamulin fumarate and residual solvent, which is applied in the field of detection of 4-methyl-2-pentanone, a residual solvent in tiamulin fumarate, can solve problems such as influence on drug safety, decrease in product quality and the like, and achieve Improve detection accuracy, easy operation, simple effect of constant temperature detection

Active Publication Date: 2015-12-09
宁夏泰瑞制药股份有限公司
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Problems solved by technology

[0007] During the synthesis of tiamulin fumarate, methanol and 4-methyl-2-pentanone (methyl isobutyl ketone) were used. The residues of these solvents not only reduce the quality of the product, but also bring harm to the safety of the drug. impact, but the original standard did not measure these two solvents

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  • Detection method of residual solvent 4-methyl-2-pentanone in tiamulin fumarate
  • Detection method of residual solvent 4-methyl-2-pentanone in tiamulin fumarate
  • Detection method of residual solvent 4-methyl-2-pentanone in tiamulin fumarate

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Embodiment Construction

[0028] Sample name: tiamulin fumarate (source: Ningxia Tairui Pharmaceutical Co., Ltd.).

[0029] Instrument: Shimadzu GC-2014 Gas Chromatograph

[0030] Chromatographic conditions: chromatographic column: capillary column (0.25mm×30m) coated with a 0.5μm G16 fixed film; detector: flame ionization detector; vaporization chamber temperature: 250°C; chromatographic column temperature: 75°C; detector temperature: 300 ℃; column flow: 1.07ml / min, split ratio 50:1. The carrier gas is high-purity nitrogen, the solvent is water, the headspace equilibration time is 30min, and the results are calculated by the external standard method.

[0031] Headspace conditions: headspace temperature 80°C heating for 30min, injection volume 1ml.

[0032] Preparation of reference solution: Precisely draw 3.2 μl of 4-methyl-2-pentanone (at room temperature, measure the respective density ρ with a liquid specific gravity balance, and calculate the mass according to M=ρV) add 10ml of water to dilute t...

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Abstract

The invention relates to a method for detecting a residual solvent 4-methyl-2-pentanone in tiamulin fumarate. The method comprises the steps of preparing a contrast solution, preparing a test piece solution, injecting the contrast solution and the test piece solution into a gas chromatograph by a gas chromatographic method in a manner of headspace sampling, and calculating the residual amount according to an external standard method. Due to the preferable selection of chromatographic conditions and the test of a test piece and contrast preparation method, the gas chromatography method for possible residue 4-methyl-2-pentanone in tiamulin fumarate is constructed; due to the optimization of a chromatographic separation system, a method for detecting the residual solvent in tiamulin fumarate serving as a veterinary drug is constructed; the methodology test and research show that the constructed methods are high in accuracy, high in specificity and high in repetitiveness; by the control on the residual solvent in tiamulin fumarate serving as the veterinary drug, the safety is guaranteed, so that infectious diseases of animals such as pigs, chicken and the like can be effectively prevented and treated.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a method for detecting residual solvent 4-methyl-2-pentanone in tiamulin fumarate. Background technique [0002] Tiamulin fumarate is a new type of semi-synthetic antibiotic for animals, which is the hydrogenated fumarate of pleuromulin extracted from the culture solution of Pleurotus mutilis in the family Agaricaceae. Clinically, it is mainly used for the prevention and treatment of chronic respiratory diseases in chickens; for mycoplasma pneumonia (asthma), mycoplasma arthritis, actinomyces pleuropneumonia, treponema dysentery, ileitis, colitis, edema disease, etc. in pigs. The drug has the characteristics of strong antibacterial activity, excellent pharmacokinetic characteristics, less dosage, and less toxicity. Clinical application shows that tiamulin fumarate is a safe and effective new veterinary drug with broad application prospects. [0003] The pharmacodynamic antibac...

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 王义张金霞包洁华郭强功
Owner 宁夏泰瑞制药股份有限公司
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