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Method for analyzing residual quantities of residual solvents in sulfadoxine

A technology of residual solvent and sulfadoxine, which is applied in the field of analysis of residual solvent residue in sulfadoxine, can solve the problems of large difference in solvent polarity and difficulty in method development, etc.

Active Publication Date: 2014-06-11
CHANGSHU JINSHEN MEDICAL PROD CO LTD
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Problems solved by technology

[0003] The existing literature may have corresponding detection methods for these residual solvents alone or two or three mixed solvents, but no detection method including these five solvents has been reported, because the solvent polarity of these five solvents is different Larger, method development is more difficult

Method used

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Embodiment Construction

[0016] The specific implementation of the present invention will be further described below in conjunction with the examples. The following examples are only used to illustrate the technical solution of the present invention more clearly, but not to limit the protection scope of the present invention.

[0017] The technical scheme of concrete implementation of the present invention is:

[0018] An analytical method for residual solvent residue in sulfadoxine, comprising the steps of:

[0019] 1) Preparation of internal standard solution: Take an appropriate amount of nitromethane, weigh it accurately, put it in a 100mL measuring bottle, add DMSO (dimethyl sulfoxide) to dissolve and dilute to the mark, and make a solution containing about 0.5mg of nitromethane per 1mL solution, as an internal standard solution;

[0020] 2) Prepare the control stock solution: take 1.5g of methanol, 440mg of DMF, 40mg of trichlorethylene, 110mg of formamide, and 2.5g of acetic acid, weigh them ...

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Abstract

The invention discloses a method for analyzing the residual quantities of residual solvents in sulfadoxine. The method comprises the following steps: (1) preparing an internal standard solution; (2) preparing a contrast stock solution; (3) preparing a contrast solution; (4) a preparing a test solution; (5) precisely measuring 5 microliters of the contrast solution, injecting the contrast solution into a gas chromatograph, and recording a chromatogram; (6) precisely measuring 5 microliters of the test solution, injecting the test solution into the gas chromatograph, and recording the chromatogram; and (7) calculating the residual quantity of each solvent in a sample according to an internal standard method according to a formula that the residual quantity of each solvent in the sample is equal to the quotient of peak areas of the residual solvent and an internal standard solvent. The method, provided by the invention, can be used for analyzing the residual quantities of various residual solvents in the sulfadoxine.

Description

technical field [0001] The invention relates to a method for analyzing residual solvent residues in sulfadoxine. Background technique [0002] Sulfadoxine is obtained through an organic synthesis process, and many organic solvents are used in the whole synthesis process. According to the classification and regulation of residual solvents in the Pharmacopoeia of the People's Republic of China, the residual amounts of the first, second and third types of solvents must be controlled within a certain range. Currently, the solvents involved in sulfadoxine are methanol, trichloroethylene, formamide, N,N-dimethylformamide, and acetic acid. [0003] The existing literature may have corresponding detection methods for these residual solvents alone or two or three mixed solvents, but no detection method including these five solvents has been reported, because the solvent polarity of these five solvents is different Larger, method development is more difficult. Contents of the inve...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
Inventor 李涛
Owner CHANGSHU JINSHEN MEDICAL PROD CO LTD
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