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HPLC detection method of related substances in Qumixin cream

A technology related to substances and detection methods, applied in the field of chemical detection, to achieve the effects of high detection efficiency, good separation and simple operation

Active Publication Date: 2020-06-23
GUANGDONG SHUNFENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In the current standard of Qumixin Cream, only the State Food and Drug Administration standard YBH20102006 (Shanghai Xinya Pharmaceutical Minhang Co., Ltd.) includes the relevant substance inspection items, but the inspection method for the related substance of Qumixin Cream in this standard can only detect a few Some impurities, while the other two current standards do not include relevant substance inspection items

Method used

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  • HPLC detection method of related substances in Qumixin cream
  • HPLC detection method of related substances in Qumixin cream
  • HPLC detection method of related substances in Qumixin cream

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Embodiment 1

[0056] A HPLC method for detecting related substances of triamcinolone acetonide acetate and miconazole nitrate in Trimixin cream, comprising the following steps:

[0057] (1) Chromatographic conditions and system suitability test:

[0058] Chromatographic column: Agilent Eclipse XDB-C18, 5μm, 4.6×250mm, with octadecylsilane bonded silica gel as filler, 0.05% ammonium acetate-methanol (25:75) as mobile phase; flow rate: 1.0ml / min ;Detection wavelength: 230nm (miconazole nitrate), 240nm (triamcinolone acetonide acetate), injection volume: 40μl; the number of theoretical plates is not less than 3000 based on the peak of miconazole nitrate, triamcinolone acetonide acetate and miconazole nitrate The resolution of azole is greater than 25, and the resolution of triamcinolone acetonide and triamcinolone acetonide is greater than 15;

[0059] (2) Solution preparation:

[0060] Preparation of the test solution: Weigh 1g of Triamcinolone cream sample (equivalent to 1mg of triamcinolo...

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Abstract

The invention belongs to the field of chemical detection, and in particular relates to a high performance liquid chromatography (HPLC) method for detecting triamcinolone acetonide acetate and miconazole nitrate related substances in Qumixin cream. The method comprises the following steps: (1) testing the chromatographic condition and system suitability; (2) preparing a solution; (3) determining, and the like. The HPLC method for detecting the triamcinolone acetonide acetate and the miconazole nitrate related substances in the Qumixin cream is simple to operate, better in degree of separation,many in detected related substances and high in detection efficiency, and has good specificity, precision and accuracy; compared with the prior art, the method can detect more impurities, and can moreeffectively control the related substances in the Qumixin cream.

Description

technical field [0001] The invention belongs to the field of chemical detection, and in particular relates to an HPLC detection method for related substances of triamcinolone acetonide acetate and miconazole nitrate in Qumixin cream. Background technique [0002] Qumixin Cream is a compound preparation for external use on the skin, which has a strong antifungal effect. There are athlete's foot net cream and Pikang cream. Qumixin Cream is a non-essential drug independently developed by my country. It was first developed and produced by Guangdong China Resources Shunfeng Pharmaceutical Co., Ltd. and was approved for sale in 1985. Due to its remarkable therapeutic effect, it has been widely used clinically. Its main components are: miconazole nitrate, triamcinolone acetonide acetate and neomycin sulfate. In order to ensure the safe use of drugs, it is usually necessary to carry out quality control on drugs, and related substances are items that must be tested for most drugs....

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/74G01N30/06
CPCG01N30/06G01N30/74
Inventor 刘庄蔚卢日刚朱健萍赵庄梁秋霞杨欣智蒋洁谭菊英李丹凤黄慧
Owner GUANGDONG SHUNFENG PHARMA
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