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Method using HPLC method to separate and measure related substances in composition of triamcinolone acetonide and econazole nitrate

A technology of econazole nitrate and related substances is applied in the field of analytical chemistry to achieve the effects of high sensitivity, good separation and strong specificity

Active Publication Date: 2016-11-23
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

None of them can be used as the control of related substances of triamcinolone acetonide and econazole nitrate composition, indicating that there is no effective detection method for related substances of triamcinolone acetonide and econazole nitrate composition in the method disclosed in the prior art

Method used

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  • Method using HPLC method to separate and measure related substances in composition of triamcinolone acetonide and econazole nitrate
  • Method using HPLC method to separate and measure related substances in composition of triamcinolone acetonide and econazole nitrate
  • Method using HPLC method to separate and measure related substances in composition of triamcinolone acetonide and econazole nitrate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Determination of triamcinolone acetonide and econazole nitrate and related substances in embodiment 1 triamcinolone acetonide econazole cream

[0054] 1. Instruments and conditions

[0055] Instrument: High performance liquid chromatography SHIMADZU 20A (SHIMADZU);

[0056] Chromatography workstation: LcSolution;

[0057] Detector: DAD;

[0058] Chromatographic column: Octadecylsilane bonded silica gel filler (SHIMADZU, VP-ODS, 150mm×4.6mm, 5μm);

[0059] Mobile phase: mobile phase A: 0.01mol / L diammonium hydrogen phosphate (adjust the pH value to 6.0 with phosphoric acid); mobile phase B: acetonitrile; use mobile phase A and B for linear gradient elution;

[0060] Detection wavelength: 225nm;

[0061] Column temperature: 35°C;

[0062] Flow rate: 1.0ml / min;

[0063] Injection volume: 10 μl.

[0064] The linear gradient elution conditions of mobile phase A and B are:

[0065]

[0066]

[0067] 2. Experimental steps

[0068] (1) Take about 10mg each of met...

Embodiment 2

[0082] Example 2 Determination results of related substances in several batches of triamcinolone acetonide econazole cream

[0083] According to the method of Example 1, several batches of triamcinolone acetonide econazole cream samples from our company were tested for related substances. The calculation results are shown in Table 1.

[0084] Table 1 Test results of several batches of samples

[0085]

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Abstract

The invention belongs to the field of analytical chemistry and particularly relates to a method using an HPLC method to separate and measure related substances in composition of triamcinolone acetonide and econazole nitrate. The method is characterized in that a reversed phase liquid chromatography method is used; octadecyl silane bonded silica gel is used as the chromatographic column of filler, and mixed liquid of a diammonium hydrogen phosphate solution and an organic solvent is used as the flowing phase to perform elution and separation. The method has the advantages that the blank of the prior art is filled up, a high-performance liquid chromatography method is used to separate and measure the triamcinolone acetonide, the econazole nitrate and the related substances in the composition of the triamcinolone acetonide and the econazole nitrate, and auxiliary material peaks can be separated effectively so as to prevent the same from affecting the detecting of the related substances. The method is good in separation degree, high in specificity, high in sensitivity, simple to operate, simple, fast, capable of guaranteeing the safety and effectiveness of products and significant to the quality control of the composition of the triamcinolone acetonide and the econazole nitrate.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a method for separating and measuring related substances in a composition of triamcinolone acetonide and econazole nitrate by HPLC. Background technique [0002] Triamcinolone acetonide is a glucocorticoid with anti-inflammatory, antipruritic and antiallergic effects. Econazole nitrate is an antifungal drug that has antibacterial activity against dermatophytes, molds and yeasts (such as Candida), and is also effective against some Gram-positive bacteria. The combination of triamcinolone acetonide and econazole nitrate can be clinically used for the treatment of dermatitis, eczema, inflammatory fungal diseases and the like. [0003] Triamcinolone Acetonide is a moderately potent fluorinated glucocorticoid with a parent ring of a steroid compound, and its structural formula is shown in Formula I. It is sensitive to acid, alkali, temperature and light, easy to degra...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 谭辉颜波
Owner CHONGQING HUAPONT PHARMA
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