A kind of high performance liquid chromatography analysis method of neconazole hydrochloride

A technology of high-performance liquid chromatography and neconazole hydrochloride, which is applied in the field of high-performance liquid chromatography analysis of neconazole hydrochloride and its preparations, can solve the problem of no literature report on the analysis method, and achieve low equipment requirements and good stability , good applicability

Active Publication Date: 2015-09-09
JIANGSU YUNYANG PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, neconazole hydrochloride and its preparations have not been marketed in China, and there is no literature report on the analytical method of the raw material drug and its preparations.

Method used

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  • A kind of high performance liquid chromatography analysis method of neconazole hydrochloride
  • A kind of high performance liquid chromatography analysis method of neconazole hydrochloride
  • A kind of high performance liquid chromatography analysis method of neconazole hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Inspection of related substances of raw materials of naconazole hydrochloride

[0035] Instrument and chromatographic conditions:

[0036] Column: ODS-3; 4.6mm×150mm, 5μm

[0037] Mobile phase: acetonitrile: water = 60:40

[0038] Detection wavelength: 286nm

[0039] Flow rate: 0.7mL / min

[0040] Column temperature: 30°C

[0041] Injection volume: 10μL

[0042] High performance liquid chromatography: Japan Shimadzu LC-20A, DAD detector

[0043] Experimental steps:

[0044] Solution preparation:

[0045] Get an appropriate amount of neconazole hydrochloride bulk drug, accurately weighed, add mobile phase to dissolve and dilute to make a solution that contains about 0.4-1mg in every 1ml, and check the need testing solution as related substance; accurately measure need testing solution 1ml, Put it in a 100ml measuring bottle, add mobile phase to dilute to the mark, shake well, and use it as a reference substance solution; accurately measure 10 μl each of the test...

Embodiment 2

[0054] Determination of raw material content of naconazole hydrochloride

[0055] Instrument and Chromatographic Conditions

[0056] Column: ODS-3; 4.6mm×150mm, 5μm

[0057] Mobile phase: acetonitrile: water = 60:55

[0058] Detection wavelength: 290nm

[0059] Flow rate: 0.7mL / min

[0060] Column temperature: 30°C

[0061] Injection volume: 20μL

[0062] Instrument: Japan Shimadzu LC-20A (DAD detector)

[0063] Solution preparation

[0064] Accurately weigh 10 mg of neconazole hydrochloride self-made raw material, put it in a 100ml volumetric flask, add an appropriate amount of mobile phase, shake to dissolve and dilute to the mark, shake well, accurately measure 20 μL and inject it into the liquid chromatograph, and record the chromatogram; Weigh 10 mg of neconazole hydrochloride self-made reference substance, put it in a 100ml measuring bottle, add an appropriate amount of mobile phase, shake to dissolve and dilute to the scale, shake well, and measure in the same wa...

Embodiment 3

[0072] Inspection of related substances in naconazole hydrochloride cream

[0073] Instrument and chromatographic conditions:

[0074] Column: ODS-3; 4.6mm×150mm, 5μm

[0075] Mobile phase: acetonitrile: water = 60:40

[0076] Detection wavelength: 286nm

[0077] Flow rate: 0.7ml / min

[0078] Column temperature: 30°C

[0079] Injection volume: 20μL

[0080] Instrument: Japan Shimadzu LC-20A (DAD detector)

[0081] Solution preparation:

[0082] Accurately weigh neconazole hydrochloride cream (approximately equivalent to 20 mg of neconazole hydrochloride), add 30 ml of acetonitrile, heat in a water bath at 80°C for 2 minutes, shake to dissolve neconazole hydrochloride, and cool in an ice bath for 2 hours. After taking it out, filter quickly, take 6ml of filtrate, add 4ml of water, shake well, filter, accurately measure 20 μL of filtrate and inject it into the liquid chromatograph, record the chromatogram, such as Figure 4 Shown; Another precision measures 1ml of the ...

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Abstract

The invention relates to a high performance liquid chromatography analysis method of neticonazole hydrochloride and belongs to the technical field of pharmaceutical analysis. The high performance liquid chromatography analysis method utilizes an octadecyl bonded silica-filled chromatographic column having specifications of 4.6mm*150mm, 5 microns or 4.6mm*200mm, 5 microns or 4.6mm*250mm, 5 microns, an acetonitrile-water mixture as a mobile phase having a volume ratio of acetonitrile to water of 45-65: 35-55, a flowing rate of 0.5-0.9mL / min, a column temperature of 30-40 DEG C, a ultraviolet detector wavelength of 280-290nm, and a sample introduction volume of 5-50 microliters. The high performance liquid chromatography analysis method of neticonazole hydrochloride can utilize a common liquid chromatograph, has low equipment requirements, utilizes two easily available mediums of the mobile phase, has high feasibility, has simple and convenient operation processes, has good applicability and can be widely used for neticonazole hydrochloride and its preparation.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular to a high performance liquid chromatography analysis method of neconazole hydrochloride and its preparation. Background technique [0002] Neticonazole Hydrochloride, chemical name 1-[(E)-2-(methylthio)-1-2-(pentyl)phenylvinyl]-1H-imidazole hydrochloride, CAS accession number for 130726-68-0. The chemical structural formula is as follows: [0003] [0004] Neconazole hydrochloride is developed by Japan Hisamitsu Pharmaceutical Co., Ltd., and is used for the treatment of skin mycosis. ) went on the market in September 1993, and the ointment (specification 10mg / g, 10g / support) went on the market in June 1998. [0005] Neconazole hydrochloride has the effect of inhibiting the growth of fungi, and when Candida albicans is cultured at a concentration of 0.08 μg / ml to 5 μg / ml, it will cause inhibition of the synthesis of mitiasterol. Intracellular K can be induced at concentr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 鲍晓芳李燕
Owner JIANGSU YUNYANG PHARMA GRP
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