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Testing method of metronidazole content in compound ketoconazole ointment

A compound ketoconazole and detection method technology, applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve the related research problems without metronidazole content detection, and achieve high accuracy, strong specificity, and good repeatability. Effect

Inactive Publication Date: 2018-04-24
FOSHAN NANHAI EASTERN ALONG PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the prior art, there is no relevant research on the detection of metronidazole content in compound ketoconazole ointment by the method of high performance liquid chromatography

Method used

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  • Testing method of metronidazole content in compound ketoconazole ointment
  • Testing method of metronidazole content in compound ketoconazole ointment
  • Testing method of metronidazole content in compound ketoconazole ointment

Examples

Experimental program
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Effect test

Embodiment 1

[0052] Chromatographic conditions: Chromatographic column type Kromasil 100-5C18 (4.6*150mm, 5μm); use pH4.0 phosphate buffer (take an appropriate amount of 0.032mol / L potassium dihydrogen phosphate solution, adjust the pH to 4.0 with phosphoric acid)—methanol (70 :30) is the mobile phase; the detection wavelength is 310nm, the flow velocity is 1.0ml / min, the column temperature is 30°C, and the number of theoretical plates is not less than 2000 according to the metronidazole peak.

[0053] Determination method: Take an appropriate amount of compound ketoconazole ointment (approximately equivalent to 50 mg of metronidazole), weigh it accurately, put it in a 500 ml conical flask with a stopper, add 200 ml of mobile phase accurately, shake, ultrasonic for 30 min, let cool, and shake well , filter, take the filtrate and filter it through a 0.45 μm filter membrane, and use the filtrate as the test solution, accurately measure 10 μl, inject it into the liquid chromatograph, and record ...

experiment example 1

[0056] 1. Detection wavelength

[0057] Take by weighing 25 mg of metronidazole reference substance into a 50 ml measuring bottle, add mobile phase (mobile phase composition is the same as in Example 1) to dissolve and constant volume, shake up. Precisely pipette 5ml to 200ml volumetric flask, use mobile phase to make up the volume, and use it as the wavelength test solution. Using ultraviolet spectrophotometry, scanning in the range of 190nm ~ 600nm, metronidazole has a maximum absorption at a wavelength of 310nm, which is used as the detection wavelength.

[0058] 2. Mobile phase

[0059] A variety of mobile phases were screened, and different ratios of water-methanol, water-methanol-acetonitrile, and different ratios, concentrations, and pHs of potassium dihydrogen phosphate solution-methanol were optimized. Some results are shown in Table 1 below. :

[0060] Table 1 The detection results of compound ketoconazole ointment (metronidazole component) under different mobile ...

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Abstract

The invention provides a testing method of the metronidazole content in compound ketoconazole ointment. According to the method, by adopting a liquid-phase chromatographic method for testing, under the dissociation function of chromatographic columns, the interference and retrograde motion of related substances, impurities, other auxiliary materials and other medicinal components are avoided, andthe related substances, impurities, other auxiliary materials and other medicinal components can be effectively dissociated and discharged out so that the tested metronidazole content in the compoundketoconazole ointment can be more truly and accurately embodied.

Description

technical field [0001] The invention relates to the field of drug detection, in particular to a method for detecting metronidazole content in compound ketoconazole ointment. Background technique [0002] Compound ketoconazole ointment is a commonly used veterinary external drug, which belongs to antimicrobial drug and is suitable for the treatment of bacterial skin diseases caused by fungi and anaerobic bacteria in dogs and cats. Its main functional ingredients are metronidazole, ketoconazole azoles, menthol. Among them, metronidazole is effective against most anaerobic bacteria and trichomonas, but ineffective against aerobic bacteria or facultative anaerobic bacteria, and can be used to treat systemic or local infections caused by anaerobic bacteria. [0003] At present, the detection of the metronidazole component in the compound ketoconazole ointment in the national standard is carried out by ultraviolet spectrophotometry. This method has simple requirements for instrum...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 陶映娴林孝崇周淑贞焦伟丽孙迎郑小霞刘昊
Owner FOSHAN NANHAI EASTERN ALONG PHARMA CO LTD
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