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Method for determining residual quantities of organic solvents in temozolomide hexyl ester

A technology of temozolomide and organic solvents, which is applied in the detection field of organic solvent residues in the antineoplastic drug temozolomide, can solve the problems of complex operation and low sensitivity, and achieve accurate content determination

Inactive Publication Date: 2013-05-22
TASLY HLDG GRP CO LTD
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  • Abstract
  • Description
  • Claims
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Problems solved by technology

However, since the drug uses organic solvents such as n-hexane, acetone, ethyl acetate, pyridine, n-hexanol, and isopropanol during the synthesis process, the above method detects the above six organic solvents, and the operation is complicated and the sensitivity is not high. Therefore, Improvements are needed to facilitate quality control of medicines

Method used

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  • Method for determining residual quantities of organic solvents in temozolomide hexyl ester
  • Method for determining residual quantities of organic solvents in temozolomide hexyl ester
  • Method for determining residual quantities of organic solvents in temozolomide hexyl ester

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Embodiment 1

[0065] Instrument and Chromatographic Conditions

[0066] Agilent6890 enhanced gas chromatograph, Agilent6890 workstation. Agilent HP-INNOWax fixative is (polyethylene glycol (PEG), 30m×0.32mm, df=0.25μm) capillary column; vaporization chamber temperature: 150°C; temperature program: initial temperature is 40°C, keep for 4min, Then raise the temperature to 110°C at 10°C / min, keep for 8min, then raise the temperature to 220°C at 40°C / min, keep for 5min; carrier gas is helium; split ratio: 5:1; injection volume 1μL; hydrogen flame ionization Detector (flame ionization detector, FID) detector temperature: 220°C.

[0067] Preparation of internal standard solution

[0068] Precisely measure a proper amount of chromatographic reagent acetonitrile, add dimethyl sulfoxide and quantitatively dilute to a solution containing 1.5 mg per 1 mL, as the internal standard solution.

[0069] Preparation of control solution

[0070] Precisely measure the right amount of n-hexane, acetone, et...

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Abstract

The invention relates to a method for determining the residual quantities of organic solvents in temozolomide hexyl ester through capillary gas chromatography. The method comprises the following steps: 1, preparing internal standard solutions; 2, preparing contrast solutions; 3, preparing a tested object solution; and 4, injecting the above solutions to a chromatograph respectively to obtain chromatograms, and calculating according to the chromatograms to obtain the component kind and content of the organic solvents in the tested object solution.

Description

Technical field: [0001] The invention relates to a method for detecting residual organic solvents in chemical drugs, in particular to a method for detecting residual organic solvents in antitumor drug temozolomide. Background technique: [0002] Temozolomide is temozolomide-8-n-hexyl carboxylate, which is an upgraded product of the anticancer drug temozolomide. Compared with the parent drug, temozolomide has better fat solubility and is easy to penetrate the skin barrier. It is suitable for superficial diseases such as skin and cervix. site of cancer treatment. [0003] The potential toxicity of organic residual solvents in pharmaceuticals has been gradually recognized by people. The limit of organic solvent residues has become one of the important items in the quality control of synthetic drugs. The residual organic solvents in the drug production process have varying degrees of toxicity and may be harmful to the human body; they may even affect the stability of the drug....

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 王国成陈莹李德馨王永峰
Owner TASLY HLDG GRP CO LTD
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