Method for detecting benzene and isopropylidene acetone residues in Avanafil by gas chromatography

A technology of mesityl oxide and gas chromatography, which is applied in the field of pharmaceutical analysis, can solve the problems of high toxicity and detection methods that cannot meet the detection sensitivity requirements, and achieve the effects of high separation, high sensitivity, and easy operation
CN109696502AInactive Publication Date: 2019-04-30重庆瑞泊莱医药科技有限公司
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
重庆瑞泊莱医药科技有限公司
Publication Date
2019-04-30
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention provides a method for detecting the content of residual solvent benzene and isopropylidene acetone in Avanafil, which comprises the steps of solution preparation and gas chromatography detection. The preparation the test sample solution includes the steps of weighing a test sample, placing the test sample in a volumetric flask, adding N- methyl pyrrolidone (NMP), strongly shaking todissolve, then diluting by water to a scale, and shaking well. The method has the advantages that the separation degree between each target peak to be detected and the adjacent impurity peak is high,there is no mutual interference, and accurate detection for benzene and isopropylidene acetone can be simultaneously realized. In addition, the method is simple and convenient to operate, easy to control and low in detection cost, and has good linear relationship, specificity, system applicability, sensitivity and high added sample recovery.
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Description

Technical field

[0001] The invention relates to avanafil, in particular to a method for detecting benzene and mesityl oxide residues in avanafil by gas chromatography, and belongs to the technical field of drug analysis. Background technique

[0002] Avanafil (Avanafil), chemical name 4-[(3-chloro-4-methoxybenzyl)amino]-2-[2-(hydroxymethyl)-1-pyrrolidinyl]-N- (2-pyrimidinylmethyl)-5-pyrimidine methanesulfonamide is a highly selective inhibitor of phosphodiesterase 5 (PDE5). Compared with other PDE5 inhibitors, avanafil is used to treat male erectile dysfunction (ED), with a faster onset time, which can take effect within 15 to 30 minutes, and the effect is not affected by eating, and the side effects are lower. In the preparation process, avanafil will use organic solvents such as ethanol and acetone, and the organic solvents such as ethanol and acetone in the laboratory have the possibility of containing benzene residue; and acetone has the potential to be derived into mesityl ...

Claims

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