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Method for detecting residual quantity of organic solvent in formoterol bulk drug

A formoterol and organic solvent technology, applied in the field of detecting organic solvent residues in formoterol raw materials

Inactive Publication Date: 2020-07-07
广州卫生职业技术学院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In the prior art, there is no report on organic solvent residues that can be used to detect formoterol fumarate and formoterol tartrate raw materials at the same time

Method used

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  • Method for detecting residual quantity of organic solvent in formoterol bulk drug
  • Method for detecting residual quantity of organic solvent in formoterol bulk drug
  • Method for detecting residual quantity of organic solvent in formoterol bulk drug

Examples

Experimental program
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Embodiment 1

[0020] 1.1 Preparation of reference substance solution and test solution:

[0021] Precisely weigh methanol, ethanol, isopropanol, dichloromethane, ethyl acetate, tetrahydrofuran, and toluene in a measuring bottle, add DMF to quantitatively dilute to make methanol, ethanol, isopropanol, dichloromethane, and acetic acid per 1 mL Ethyl ester, tetrahydrofuran and toluene are mixed solutions of 120, 200, 200, 26, 200, 30 and 36 μg respectively, as the reference solution;

[0022] Accurately weigh 200 mg of formoterol tartrate crude drug, put it in a 20 mL headspace bottle, add 5.0 mL of DMF, seal it, and make it dissolve to obtain the test solution A;

[0023] Accurately weigh 200 mg of formoterol fumarate crude drug, put it in a 20 mL headspace bottle, add 5.0 mL of DMF solvent, seal it, and make it dissolve to obtain the test solution B.

[0024] 1.2 Chromatographic conditions:

[0025] Adopt HP-5 capillary column (30m×0.32mm×0.25μm), hydrogen flame ionization detector, carrie...

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Abstract

The invention relates to a method for detecting the residual quantity of an organic solvent in a formoterol bulk drug, and belongs to the technical field of drug analysis. The detection method comprises the following steps: preparing a reference substance solution and a test sample solution, and detecting by using a gas chromatography external standard method under the chromatographic conditions:an HP-5 capillary column and a hydrogen flame ionization detector are adopted, nitrogen is used as carrier gas, and the flow rate is 0.8-1.2 mL / min; the temperature of a sample inlet is 195-205 DEG C,and the split ratio is 1: 1, the detector temperature is 245-255 DEG C, the hydrogen flow rate is 30 mL / min, the air flow rate is 300 mL / min, and the tail blowing rate is 25 mL / min; the heating temperature of the headspace bottle is 100 DEG C, the quantitative loop is 110 DEG C, the transmission line is 120 DEG C, the heating time of the headspace bottle is 30 minutes, and the pressurizing time is 0.2 minute. The method has the characteristics of simplicity, convenience, quickness and accuracy, and can be used for simultaneously detecting the residual quantity of seven organic solvents in formoterol tartrate.

Description

technical field [0001] The invention relates to a method for detecting residual organic solvents in formoterol raw materials, belonging to the technical field of drug analysis. Background technique [0002] Formoterol is a highly effective drug for chronic obstructive pulmonary disease, which can significantly improve the incidence of asthma patients. The pharmacological activity of the (R, R) configuration of formoterol is 1 000 times that of the (S, S) configuration, and shows less toxicity, and its bronchodilator effect is twice that of the racemate when used alone . Therefore, the single use of (R, R)-formoterol, that is, arformoterol, can not only enhance the action activity, reduce the dosage, but also reduce the occurrence of toxic and side effects. In the production process of formoterol tartrate and formoterol fumarate raw materials, organic solvents such as methanol, ethanol, isopropanol, dichloromethane, ethyl acetate, tetrahydrofuran, toluene, etc. are used, in...

Claims

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Application Information

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IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/884
Inventor 郭俐麟唐冰雯冯月燕叶红庆詹爱萍崔慧通李智斌周伟平
Owner 广州卫生职业技术学院
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