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
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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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