Method for determining apixaban cleaning residues by high performance liquid chromatography

A high-performance liquid chromatography and apixaban technology, which is applied in the field of high-performance liquid chromatography for the determination of apixaban cleaning residues, can solve the problems of irrelevant reports of trace residues, and achieve improved peak shape and effective detection of trace residues , Improve reliability, reduce the effect of detection limit
CN104316637AActive Publication Date: 2015-01-28JIANGSU BAOZONG & BAODA PHARMACHEM
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
JIANGSU BAOZONG & BAODA PHARMACHEM
Publication Date
2015-01-28

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Abstract

The invention relates to a method for determining apixaban cleaning residues by high performance liquid chromatography, and belongs to the field of chemical pharmaceutical detection. The invention aims at providing a method for determining the apixaban cleaning residues. The method is easy and quick to operate and accurate and reliable in determination results to evaluate a cleaning effect so as to ensure medicine quality and medication safety. The high performance liquid chromatography for determining the apixaban cleaning residues, which is disclosed by the invention, is easy and quick to operate, and accurate and reliable in the determination results, so that the cleaning effect of the equipment can be evaluated effectively. According to the high performance liquid chromatography, a 280 nm flow phase is selected, so that the detection limit is reduced effectively. A chromatographic column temperature selects 40 DEG C, so that the peak type can be improved effectively, and minimal residues can be effectively detected; methanol is selected to serve as a solvent, and is not absorbed in the wavelength, so that the interference on the detection caused by the solvent is avoided, and the reliability of the detection method is improved.
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Description

technical field

[0001] The invention relates to a high-performance liquid chromatography method for determining the cleaning residue of apixaban, belonging to chemical

[0002] field of pharmaceutical testing. Background technique

[0003] The raw material drug production process inevitably involves the problem of shared equipment. If the equipment is switched during the shared link, if the equipment is not cleaned completely, the residue of the material from the previous production will inevitably be brought into the next production. Due to the difference in drug toxicity, The size of the residue will directly affect the safety and quality of the drug, so it is very necessary to control the cleaning residue to a reasonable limit, and it is also required by the GMP regulation as the minimum pharmaceutical requirement. Generally, impurities are allowed to exist in the product within the allowable range of safety. Therefore, it is very necessary and urgent to use a certain in...

Claims

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