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HPLC detection method of neomycin sulfate component in Qumixin cream

A neomycin sulfate and detection method technology, applied in the field of chemical detection, can solve the problems of time-consuming and labor-intensive neomycin sulfate, uncontrolled neomycin sulfate content, etc., and achieve the effect of stable detection method, small error and high detection efficiency

Active Publication Date: 2021-06-01
GUANGDONG SHUNFENG PHARMA
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Problems solved by technology

Among the current standards of Qumixin Cream, the local standards for chemicals in the "National Drug Standards" have been upgraded to the second national standard volume, which does not control the content of neomycin sulfate; the standards YBH16902004 and YBH20102006 of the State Food and Drug Administration are determined by potency method However, it is time-consuming and laborious to use the potency method to determine the content of neomycin sulfate in Qumixin cream, and the applicability of the potency method in these two standards needs further investigation

Method used

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  • HPLC detection method of neomycin sulfate component in Qumixin cream
  • HPLC detection method of neomycin sulfate component in Qumixin cream
  • HPLC detection method of neomycin sulfate component in Qumixin cream

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Embodiment 1

[0050] A kind of HPLC detection method of neomycin sulfate component in Qumixin emulsifiable cream, comprises the following steps:

[0051] (1) Chromatographic conditions and system suitability test:

[0052] Use hydrophilic octadecylsilane bonded silica gel as filler, chromatographic column: Waters Xselect HSS T3 column, 4.6×250mm, 5μm or equivalent column, mobile phase: 0.15mol / L trifluoroacetic acid solution, flow rate: 1ml / min, injection volume: 20μl, column temperature: 30°C, CAD detector nebulization temperature: 45°C, the retention time of neomycin C relative to neomycin B is 0.85-0.95 (about 0.9), new The separation degree between mycin C and main peak neomycin B is not less than 3.0;

[0053] (2) Solution preparation:

[0054] ①Preparation of the test solution: Weigh 0.5g of this product, weigh it accurately, put it in a separatory funnel, add 25ml of dichloromethane, shake to disperse the cream base, then add 20ml of water precisely, shake for three minutes and the...

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Abstract

The invention belongs to the field of chemical detection, and in particular relates to an HPLC detection method for the neomycin sulfate component in Qumixin cream, including (1) chromatographic conditions and system applicability test (2) solution preparation (3) determination and other steps . The HPLC detection method of the neomycin sulfate component in Qumixin emulsifiable cream of the present invention has the advantages of simple operation, high detection efficiency, small error, strong specificity, relatively stable detection method, less affected factors, and wide applicability ; The accuracy, precision, specificity, detection limit, etc. of the method all meet the methodological verification requirements, and have strong practicability. The method is used to analyze the neomycin sulfate group in the Trimixin cream produced by various enterprises. The detection can be carried out separately, and the content of each component of neomycin sulfate can be detected quickly and accurately, which is beneficial to the determination of the samples of Trimethin cream produced by various enterprises.

Description

technical field [0001] The invention belongs to the field of chemical detection, and in particular relates to an HPLC detection method for the neomycin sulfate component 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 at present, and its main components are: miconazole nitrate, triamcinolone acetonide acetate and neomycin sulfate. [0003] Neomycin sulfate (Neomycin sulfate) is one of the main components of Quamixin cream. It is a multi-component aminoglycoside antibiotic. It has a good antibacterial effect on Staphylococcus and Cor...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 卢日刚朱健萍刘庄蔚赵庄蒋洁梁秋霞杨欣智邓鸣朱荣颜其双王娟
Owner GUANGDONG SHUNFENG PHARMA
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