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Detection method for residual solvent in tilmicosin phosphate

A technology of tilmicosin phosphate and residual solvents, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., and can solve the problems of drug safety impact and product quality reduction

Active Publication Date: 2015-04-08
宁夏泰瑞制药股份有限公司
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Problems solved by technology

[0005] In the synthesis process of tilmicosin phosphate, butyl peracetate and n-butanol are used. The residue of these solvents not only reduces the quality of the product, but also affects the safety of the drug. However, the original standard did not regulate these two solvents. Determination, for this reason we use gas chromatography to establish the detection method of butyl acetate and n-butanol, and stipulate reasonable limits to ensure the safety of tilmicosin phosphate

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  • Detection method for residual solvent in tilmicosin phosphate
  • Detection method for residual solvent in tilmicosin phosphate
  • Detection method for residual solvent in tilmicosin phosphate

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Embodiment Construction

[0018] Sample name: tilmicosin phosphate, (source: Ningxia Tairui Pharmaceutical Co., Ltd.).

[0019] Instrument: Shimadzu GC-2014 Gas Chromatograph

[0020] Chromatographic conditions: Chromatographic column: Rtx-WAX capillary column with polyethylene glycol (PEG) as the stationary phase (column length 30m, inner diameter 0.53mm, film thickness 1.0μm), column temperature is constant: 30-60°C; use hydrogen Flame ionization detector detection, detector temperature 240-260°C; inlet temperature 200°C; column flow rate 1.0-2.0ml / min; carrier gas: high-purity nitrogen; headspace conditions: vaporization chamber temperature 80°C heating 20 ~40min, injection volume 1ml.

[0021] Preparation of reference substance solution: Accurately weigh the appropriate amount of butyl acetate and n-butanol reference substances, add water to make a solution containing 50 μg of butyl acetate and n-butanol respectively per 1 ml, put 10 ml in a headspace bottle, seal it with a cap, Heat at 80°C for ...

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Abstract

A detection method for a residual solvent in tilmicosin phosphate comprises: preparing a reference substance solution, preparing a to-be-detected sample solution, employing a gas chromatography method, injecting the reference substance solution and the to-be-detected sample solution into a gas chromatograph by a headspace sampling manner, and calculating the residual quantity according to an external standard method. Through optimization of chromatographic conditions and the tests on preparation methods of the to-be-detected sample and the reference substance, a gas chromatograph method is established for detecting residues such as butyl acetate and n-butanol possibly existing in tilmicosin phosphate; through optimization of the chromatographic separation system, the detection method for the residual solvent in the veterinary drug tilmicosin phosphate; methodological verification tests show that the established method is high in accuracy, strong in specificity and good in reproducibility; and by controlling the content of the residual solvent in the veterinary drug tilmicosin phosphate, the safety of the veterinary drug tilmicosin phosphate is guaranteed, and thus infectious diseases of animals such as cattle, goat, sheep, cow, pig, chicken and the like are relatively effectively controlled.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a method for detecting residual solvents in tilmicosin phosphate. Background technique [0002] Tilmicosin is a new type of macrolide antibiotic specially used for animals. It is mainly used clinically for infectious diseases of cattle, pigs, chickens, sheep, goats, rabbits, etc., especially for respiratory diseases of livestock and poultry, and has achieved remarkable results. curative effect. The drug has the characteristics of strong antibacterial activity, excellent pharmacokinetic characteristics, less dosage, and less toxicity. Clinical application shows that: tilmicosin is a safe and effective new veterinary drug with broad application prospects. [0003] Tilmicosin has broad-spectrum antibacterial activity similar to tylosin, and has inhibitory effects on Gram-positive bacteria and some Gram-negative bacteria, mycoplasma, spirochetes, etc. Bacillus and mycoplasma have...

Claims

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Application Information

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