Content detection method of chlorhexidine gluconate

A technology of chlorhexidine gluconate and a detection method, which is applied in the field of chemical detection, can solve the problems of long time consumption, unsuitable content detection, low accuracy and the like

Pending Publication Date: 2020-02-04
FOSHAN NANHAI EASTERN ALONG PHARMA CO LTD
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AI Technical Summary

Problems solved by technology

The content detection method of dilute chlorhexidine gluconate solution in Chinese Pharmacopoeia is to adopt ultraviolet-visible spectrophotometry to detect, and the accuracy of this detection method is not high; Content detection is detected by high performance liquid chromatography (HPLC, High Performance Liquid Chromatography) with gradient elution, but the elut

Method used

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  • Content detection method of chlorhexidine gluconate
  • Content detection method of chlorhexidine gluconate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] A content detection method of chlorhexidine gluconate, comprising the following steps:

[0039] 1) Accurately weigh compound miconazole nitrate shampoo 10g, dilute it with solvent, and be mixed with the need testing solution that chlorhexidine gluconate content is about 0.1mg / mL; Described solvent is made of acetonitrile, 0.05mol / mL 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.

[0040] 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.

[0041] The chromatographic conditions are:

[0042] Chromatographic column: ZORBZX Eclipse XDB-C18Analytical 4.6×150mm 5-Micron;

[0043] Mobile phase: composed of acetonitrile, 0.05mol / L disodium hydrogen phosphate solution and triethylamine in a volume ratio of 45:65:1, and adjust the pH value to 3.0...

Embodiment 2

[0050] Embodiment 2 system suitability verification

[0051]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 259nm. The number of theoretical plates by chlorhexidine gluconate should be greater than 2000, and the degree of separation should be greater than 1.5.

[0052] 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 chlorhexidine gluconate, and inject it into the chromatograph for detection and verification.

[0053] Results: The theoretical plate number of chlorhexidine gluconate was greater than 2000, and the separation degree between the peak of chl...

Embodiment 3

[0054] Embodiment 3 specificity test

[0055] Precisely measure 10 μL of the diluent (methanol) and inject it into the liquid chromatograph, record the spectrum, and obtain a blank spectrum;

[0056] The chlorhexidine gluconate 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 ); Know that the retention time of chlorhexidine gluconate is about 4.0min from the collection of graphs; Compound miconazole nitrate test sample is added mobile phase and is made into the solution containing 0.1mg chlorhexidine gluconate in every 1mL about, precision Measure 10 μ L and inject liquid chromatograph, carry out by the chromatographic condition of embodiment 1, record chromatogram, obtain need testing co...

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Abstract

The invention relates to a content detection method of chlorhexidine gluconate. The method comprises the following steps: diluting a to-be-detected sample with a solvent to obtain a testing product solution of which the chlorhexidine gluconate content is 0.02mg/mL-0.2mg/mL; injecting 10 microliters-20 microliters of the testing product solution into a high performance liquid chromatograph for detection, and obtaining the content of the chlorhexidine gluconate in the to-be-detected sample, wherein chromatographic conditions for high performance liquid chromatography detection are as follows: achromatographic column: octadecylsilane chemically bonded silica is taken as a filler; a mobile phase: the volume ratio of acetonitrile, phosphate solution and triethylamine is (35-50):(50-65):1, pH value is 3+/-0.1, the concentration of the phosphate solution is 0.02mol/L-0.08mol/L; velocity of flow: 0.5mL/min-1.5mL/min; column temperature: 25-35 DEG C; detection wavelength: 258-259nm; and the solvent is the same as the mobile phase. In the method provided by the invention, conditional response value is high, under a situation of guaranteeing constituent resolution, peaks of the chlorhexidinegluconate forms quickly, content of the chlorhexidine gluconate can be determined quickly, detection working efficiency is improved, and control of quality of products is facilitated.

Description

technical field [0001] The invention relates to the technical field of chemical detection, in particular to a content detection method of chlorhexidine gluconate. 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 chlorhexidine gluconate with antibacterial effect in the shampoo is a new type of veterinary shampoo preparation for pets. [0003] At present, there is no quality standard for this type of preparation and an effective method for detecting the content of chlorhexidine gluconate therein. The content detection method about dilute chlorhexidine gluconate solution in Chinese Pha...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/04G01N30/74G01N30/86G01N30/34
CPCG01N30/02G01N30/04G01N30/74G01N30/8634G01N30/34G01N2030/047
Inventor 徐奇清孙迎聂姣付良凯赵奉君
Owner FOSHAN NANHAI EASTERN ALONG PHARMA CO LTD
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