Method for testing amorolfine hydrochloride and interferent of amorolfine hydrochloride

A technology for the determination of amorolfine hydrochloride, which is applied in the field of analysis and detection of pharmaceutical ingredients, can solve the problems of complex preparation process, increased production cost, waste of resources, etc.

Active Publication Date: 2018-03-06
上海正大通用药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When the proportion of methanol in the mobile phase increases and the pH value of the buffer decreases, the separation of amorolfine hydrochloride and interfering substances is not ideal, and at the same time, it will damage the ODS column
The problem is that the mobile phase has many components and the preparation process is complicated, which inc

Method used

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  • Method for testing amorolfine hydrochloride and interferent of amorolfine hydrochloride
  • Method for testing amorolfine hydrochloride and interferent of amorolfine hydrochloride
  • Method for testing amorolfine hydrochloride and interferent of amorolfine hydrochloride

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0078] 1. Experimental part

[0079] 1.1 Sample pretreatment

[0080] The preparation of need testing solution: take amorolfine hydrochloride emulsifiable paste sample, add the methanol solution containing 0.4~0.6% phosphoric acid, vortex instrument oscillation shakes 15~25min, the quality that amorolfine hydrochloride emulsifiable paste sample adds ( g), and the ratio of the volume (ml) added to the phosphoric acid-containing methanol solution is 3:14 to 3:16. Then, sonicate at 45-55°C for 10-20 minutes, cool to room temperature, dilute to volume with pure water, shake well, refrigerate and centrifuge, filter, and take the filtrate as the test solution. Wherein, the conditions of refrigerated centrifugation are as follows: the centrifugation temperature is -5-0° C.; the centrifugation time is 15-30 minutes; the centrifugation speed is 8000-14000 rpm. Filtration is 0.45 μm membrane filtration.

[0081]Preparation of the reference substance solution: Weigh the amorolfine hyd...

Embodiment 2

[0098] 1. Experimental part

[0099] 1.1 Sample pretreatment

[0100] The preparation of need testing solution: precision takes amorolfine hydrochloride emulsifiable paste sample 3g, puts in 25ml measuring bottle, adds the methanol solution 15ml that contains 0.5% phosphoric acid and shakes for 20min, the amorolfine hydrochloride emulsifiable paste sample adds The ratio of the mass (g) to the volume (ml) of the phosphoric acid-containing methanol solution is 3:15. Then, sonicate in a water bath at 50°C for 15 minutes, cool to 20-25°C, dilute to volume with pure water, shake well, refrigerate and centrifuge, filter, and take the filtrate as the test solution. Wherein, the conditions of refrigerated centrifugation are as follows: the centrifugation temperature is 0° C.; the centrifugation time is 15-30 min; and the centrifugation speed is 8000-14000 rpm. Filtration is 0.45 μm membrane filtration.

[0101] Preparation of the reference substance solution: Weigh the amorolfine h...

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Abstract

The invention provides a method for testing amorolfine hydrochloride and interferent of amorolfine hydrochloride. The method comprises the following steps: 1) preparing a test sample solution; 2) preparing a control solution; 3) performing detection. According to the method for testing the amorolfine hydrochloride and the interferent of the amorolfine hydrochloride, pretreatment with optimized conditions and an HPLC (High Performance Liquid Chromatography) detection method are implemented, target components can be effectively separated from the interferent, the contents of the amorolfine hydrochloride and the interferent of the amorolfine hydrochloride are accurately tested, control on amorolfine hydrochloride and interferent of the amorolfine hydrochloride in amorolfine hydrochloride cream products is achieved, and the quality of an amorolfine hydrochloride product is ensured.

Description

technical field [0001] The invention belongs to the technical field of analysis and detection of pharmaceutical components, and relates to a method for determining amorolfine hydrochloride and its interferents, in particular to a method for analyzing and measuring amorolfine hydrochloride and its interferents by using high performance liquid chromatography. Background technique [0002] Amorolfine hydrochloride, chemical name is rac-cis-4[3-[4-(1,1-dimethyl-propyl)phenyl]-2-methylpropane]-2,6-dimethyl Base-morpholine hydrochloride is a broad-spectrum antifungal drug. In the body, amorolfine hydrochloride, as the main medicinal ingredient, inhibits the reductase and isomerase required for the conversion of hypoergosteroids into ergosterol, promotes the accumulation of hypoergosteroids, and greatly reduces ergosteroids; thereby damaging the cell membrane structure and function, to inhibit and kill fungi; at the same time, amorolfine hydrochloride also causes abnormal chitin a...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 魏冬任寅马媛媛徐若娴顾兆姝徐子平
Owner 上海正大通用药业股份有限公司
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