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Content detecting method of miconazole nitrate

A technology of miconazole nitrate and a detection method, which is applied in the field of chemical detection and can solve the problems that there is no compound shampoo preparation miconazole nitrate, etc.

Inactive Publication Date: 2020-02-04
FOSHAN NANHAI EASTERN ALONG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, at present, there is no effective method for quality standards and detection of miconazole nitrate content in compound shampoo preparations

Method used

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  • Content detecting method of miconazole nitrate
  • Content detecting method of miconazole nitrate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] A method for detecting the content of miconazole nitrate, comprising the following steps:

[0040] 1) Accurately weigh compound miconazole nitrate shampoo 10g, dilute it with an appropriate amount of solvent, be mixed with the need testing solution that miconazole nitrate content is about 0.1mg / mL; Described solvent is made of acetonitrile, 0.05mol / L Disodium hydrogen phosphate solution and triethylamine are composed at a volume ratio of 45:55:1, and the pH value is adjusted to 3.0 with phosphoric acid solution.

[0041] 2) Get 10 μ L of the test solution, inject it into a high-performance liquid chromatograph for detection, and obtain the following: figure 1 The chromatogram shown.

[0042] The chromatographic conditions are:

[0043] Chromatographic column: ZORBZX Eclipse XDB-C18Analytical 4.6×150mm 5-Micron;

[0044] Mobile phase: composed of acetonitrile, 0.05mol / L disodium hydrogen phosphate solution and triethylamine in a volume ratio of 45:35:1, and adjust the...

Embodiment 2

[0051] Embodiment 2 system suitability verification

[0052] Chromatographic conditions: a chromatographic column using octadecylsilane bonded silica gel as a filler; the mobile phase is composed of acetonitrile-0.05mol / L disodium hydrogen phosphate solution-triethylamine in a volume ratio of 45:55:1, with phosphoric acid Adjust the pH to 3.0; the column temperature is 30°C, the flow rate is 1.0mL / min, and the detection wavelength is 226nm. The number of theoretical plates according to miconazole nitrate should be greater than 2000, and the degree of separation should be greater than 1.5.

[0053] Take an appropriate amount of compound miconazole nitrate shampoo, add mobile phase to make about 10 μL each of the test solution containing 0.1 mg / mL miconazole nitrate, and inject it into the chromatograph for detection and verification.

[0054] Results: The theoretical plate number of miconazole nitrate was more than 2000, and the separation degree between the peak of miconazole...

Embodiment 3

[0055] Embodiment 3 specificity test

[0056] Precisely measure 10 μL of the diluent (methanol) and inject it into the liquid chromatograph, record the spectrum, and obtain a blank spectrum;

[0057] The miconazole nitrate reference substance plus mobile phase is made into a solution containing about 0.1mg in every 1mL, and precision measures 10 μ L and injects it into a liquid chromatograph, carries out according to the chromatographic conditions of Example 1, records the chromatograms, and obtains the contrast collection of collections (refer to figure 2 ); From the collection of graphs, it is known that the retention time of miconazole nitrate is about 3.0min; the compound miconazole nitrate test sample is added with mobile phase to make a solution containing about 0.1mg miconazole nitrate in every 1mL, and accurately measure 10 μ L inject liquid chromatograph, carry out by the chromatographic condition of embodiment 1, record chromatogram, obtain need testing collection o...

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Abstract

The invention relates to a content detecting method of miconazole nitrate. A to-be-detected sample is diluted into a test solution with the content of the miconazole nitrate being 0.02 mg / mL-0.2 mg / mLthrough a solvent; 10 [mu]L-20 [mu]L of the test solution is taken to be injected into a high performance liquid chromatograph to be detected, and the content of the miconazole nitrate in the to-be-detected sample is obtained; and the chromatographic conditions during high performance liquid chromatographic detection are that a chromatographic column takes octadecylsilane chemically bonded silicaas a filler, a flowing phase is prepared from acetonitrile, a phosphate solution and triethylamine according to the volume ratio of (35 to 50):(50 to 65):1, the pH value of the flowing phase is 3+ / -0.1, the concentration of the phosphate solution is 0.02 mol / L-0.08 mol / L, the flowing speed is 0.5 mL / min-1.5 mL / min, the column temperature is 25 DEG C-35 DEG C, the detection wavelength is 210 nm-240 nm, and the solvent and the flowing phase are the same in composition. The condition response value of the method is high, peak appearing of the miconazole nitrate is quick, the content of the miconazole nitrate can be measured quickly, the working efficiency of detection is improved, and the quality of a product is controlled advantageously.

Description

technical field [0001] The invention relates to the technical field of chemical detection, in particular to a method for detecting the content of miconazole nitrate. Background technique [0002] Shampoo is the transliteration of the foreign word "shampoo", mainly composed of detergent, auxiliary detergent and additives, which mainly have the function of cleaning and maintaining hair; additives can meet the special needs of shampoo and give shampoo a variety of different effects, so that the role of shampoo Continuous refinement, the compound shampoo preparation made by adding medicinal ingredients such as miconazole nitrate with antibacterial effect in the shampoo is a new type of veterinary shampoo preparation for pets. [0003] The content detection method of traditional miconazole nitrate is determined by potentiometric titration, and its titrant is usually 0.1mol / L perchloric acid titration; This method has certain limitations in its application. Its sensitivity may af...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/04G01N30/74G01N30/86G01N30/34
CPCG01N30/02G01N30/04G01N30/74G01N30/8634G01N30/34G01N2030/047
Inventor 徐奇清孙迎聂姣叶小妹赵奉君
Owner FOSHAN NANHAI EASTERN ALONG PHARMA CO LTD
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