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Method for determining content of trimethoprim and various sulfonamides in medicine and application of method

A technology of trimethoprim and medicines, applied in the field of quality analysis of medicines, can solve the problems of undisclosed content detection methods, unfavorable qualitative and quantitative analysis, cumbersome operation steps, etc., and achieves simple and fast preparation operations, short measurement time, and reduced pollution effect

Active Publication Date: 2020-11-17
贵州省兽药饲料检测所
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] After checking the literature, in the Chinese invention patent specification CN201810516610.5, a method for extracting and analyzing sulfonamides using a DPX tip-type dispersive solid-phase microextraction column, by using a DPX tip-type dispersive solid-phase microextraction column for extraction-purification operation As follows: First balance the DPX Tips TM-CX tip-type dispersive solid-phase microextraction column with methanol and formic acid aqueous solution in turn—pipe the purification solution through the column—wash the column with formic acid aqueous solution and methanol—elution with eluent—collection and elution Liquid-nitrogen blow-drying-the residue is dissolved in formic acid-methanol aqueous solution-vortex mixing-centrifugation-take the supernatant-high performance liquid chromatography-tandem mass spectrometry. Perform accurate qualitative and quantitative analysis
In the Chinese invention patent specification CN201510736962.8, a method for separating and enriching the determination of 12 kinds of residual drugs in the water environment, the safety detection of trace organic pollutant residues in the water environment, the specific method: water sample treatment - solid phase extraction combined with ultrasonic assisted dispersion Liquid-liquid microextraction (UA-DLLME) enrichment and concentration (sample vortex treatment-ultrasonic treatment-centrifugation-nitrogen drying)-UHP liquid chromatography-mass spectrometry combined detection (UHP liquid chromatography separation: gradient elution-mass spectrometry detection), directly determine the content of 12 kinds of commonly used drugs in the water environment (drinking water, tap water, river water, sewage treatment plant influent and effluent water), and the 12 kinds of antibiotics are ketoprofen, ciprofloxacin, tinidazole, tolfina acid, sulfadiazine, sulindac, naproxen, sulfamethoxazole, chloramphenicol, cefuroxime axetil, piroxicam, mefenamic acid, the operation in this method is cumbersome, and the types of pollutants in the water environment There are many, there are various forms, the concentration is low, and the environmental matrix is ​​relatively complicated. This method is not conducive to accurate qualitative and quantitative analysis. Moreover, this technology does not disclose the content detection method of various sulfa drugs, and whether different pharmaceutical preparations There is a method of using this sulfa drug to replace other sulfa drugs and adulteration of preparations

Method used

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  • Method for determining content of trimethoprim and various sulfonamides in medicine and application of method
  • Method for determining content of trimethoprim and various sulfonamides in medicine and application of method
  • Method for determining content of trimethoprim and various sulfonamides in medicine and application of method

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Effect test

Embodiment 1

[0091] The concrete method of content determination of compound sulfadiazine sodium injection comprises the following steps:

[0092] (1) Prepare mobile phase and set chromatographic conditions

[0093] The mobile phase is 0.1% phosphoric acid solution-acetonitrile, and the gradient elution program is as follows:

[0094]

[0095]

[0096] Set the chromatographic conditions as measuring wavelength 240nm, flow rate as 1.0ml / min, injection volume as 10μl, chromatographic column as C 18 (octadecylsilane bonded silica gel column);

[0097] (2) Preparation of standard stock solution and standard working solution

[0098] Preparation of standard stock solution Precisely weigh about 50mg of sulfadiazine reference substance and about 10mg of trimethoprim, put them in 50ml measuring bottles respectively, add an appropriate amount of methanol, sonicate for 10-20min, take it out, let it cool, dilute to the mark with methanol, Mix well to obtain a reference substance stock soluti...

Embodiment 2

[0105] The concrete method of content determination of compound sulfamethoxine injection comprises the following steps:

[0106] Adopt the same measuring method of embodiment 1, assay result:

[0107] Accurately measure 10 μl each of the test solution or the reference substance working solution and inject it into the liquid chromatograph, and calculate the content by the peak area according to the external standard method. The contents of sulfamethoxine and trimethoprim in this batch of compound sulfamethoxine injection were measured to be 92.73% and 94.98% of the labeled amount respectively. The contents of sulfamethoxine and trimethoprim measured by the traditional method are respectively 99.0% and 98.1% of the marked amount, so it can be seen that the assay method of the present invention has high accuracy, good stability, more sensitive detection, environmental protection, and professional One and accurate, improve the safety and reliability of medication.

Embodiment 3

[0109] The concrete method of content determination of compound sulfamethoxine tablet comprises the following steps:

[0110] Adopt the same measuring method of embodiment 1, assay result:

[0111] Accurately measure 10 μl each of the test solution or the reference substance working solution and inject it into the liquid chromatograph, and calculate the content by the peak area according to the external standard method. The contents of sulfamethoxine and trimethoprim in the batch of compound sulfamethoxine tablets were measured to be 91.11% and 89.12% of the labeled amount respectively. The content of sulfamethoxine and trimethoprim measured by the traditional method is 92.36% and 91.45% of the labeled amount respectively. It can be seen that the assay method of the present invention has high accuracy, good stability, more sensitive detection, environmental protection and specificity. And accurate, improve the safety and reliability of medication.

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Abstract

The invention relates to a method for determining the content of trimethoprim and various sulfonamides in a drug. The method comprises the following steps: preparing a mobile phase, determining chromatographic conditions, preparing a reference solution and a test solution, and determining the content. According to the method disclosed by the invention, the contents of trimethoprim, sulfadiazine, sulfathiazole, sulfadimidine, sulfamethoxydiazine, sulfamonomethoxine, sulfachloropyridazine, sulfamethoxazole, sulfachloropyrazine and sulfaquinoxaline in the medicine can be determined, and a new method is provided for determining whether the preparation is adulterated or not; the method has the advantages of simple and rapid operation, accurate and reliable result, short determination time and the like.

Description

technical field [0001] The invention relates to the field of quality analysis of medicines, in particular to a method for measuring the content of various sulfonamide drugs and trimethoprim, and its application in identifying whether a drug product is adulterated. Background technique [0002] As a class of chemotherapeutic drugs, sulfa drugs have a history of more than 80 years since the discovery of the first sulfa drug, prontosil, in 1935. There are more than 8,500 kinds of such drugs synthesized successively, including There are more than 20 kinds of medical value. Sulfonamides have the advantages of broad antibacterial spectrum, oral administration, fast absorption, stable properties, and convenient use. But also have the defects such as weak antibacterial effect, many adverse reactions, easy drug resistance of bacteria, large dosage and long course of treatment. After the discovery of antibacterial synergists such as trimethoprim, the combined use of sulfonamide drug...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8675G01N2030/047
Inventor 陈锡龙赵贵王庆红孙真峥杨强谢丽丽罗永成
Owner 贵州省兽药饲料检测所
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