Content determination method of mometasone furoate cream

A technique for measuring mometasone furoate and its determination method, which is applied in the field of content determination of mometasone furoate cream, can solve problems such as inability to adapt to product quality detection, small separation, and inability to accurately determine product content, achieving high sensitivity and easy operation. Simple and specific effect

Pending Publication Date: 2021-07-02
GUANGZHOU BAIYUNSHAN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In the research and development process, the inventor obtained a new mometasone furoate cream by improving the formula and preparation method of mometasone furoate cream. However, according to the current content detection method, mometasone furoate in the obtained liquid chromatogram The front of the main peak of Misone peak and its degradation products, the degree of separation is small, and the content of the product cannot be accurately determined
[0005] In view of this, the present invention provides a kind of content detection method of mometasone furoate emulsifiable cream, solves the quality detection problem that current standard cannot adapt to this product

Method used

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  • Content determination method of mometasone furoate cream
  • Content determination method of mometasone furoate cream
  • Content determination method of mometasone furoate cream

Examples

Experimental program
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Embodiment 1

[0057] Embodiment 1 chromatographic conditions and system suitability test

[0058] Use octylsilane bonded silica gel as filler (4.6mm×250mm, 5μm or equivalent performance chromatographic column); use methanol-water (65:35) as mobile phase; flow rate is 1.0ml / min; column temperature is 25°C , the detection wavelength is 254nm. Take about 50mg of mometasone furoate, put it in a 50ml measuring bottle, add an appropriate amount of methanol, shake or sonicate to dissolve, add 5ml of 3mol / L hydrochloric acid solution, let it stand at room temperature for 4 hours, add 5ml of 3mol / L sodium hydroxide solution, and use Dilute methanol to the mark, shake well, accurately measure 2ml, put it in a 10ml measuring bottle, dilute to the mark with diluent [methanol-water-glacial acetic acid (65:35:0.2)], shake well, and use it as a system suitability solution.

[0059] Take the system suitability solution for five consecutive injections, 20 μL each time, record the chromatogram, and determin...

Embodiment 2

[0066] The assay method of embodiment 2 mometasone furoate cream

[0067] (1) Preparation of internal standard solution: take an appropriate amount of beclomethasone dipropionate, add acetonitrile to dissolve and dilute to a solution containing about 0.5 mg per 1 mL, to obtain final product;

[0068] (2) Preparation of reference substance solution: Take an appropriate amount of mometasone furoate reference substance, accurately weighed, add acetonitrile to dissolve and quantitatively dilute to make a solution containing about 0.14mg per 1mL, to obtain solution 1, accurately measure 15mL, and accurately measure Add 15 mL of the internal standard solution obtained in step (1), shake well, accurately measure 5 mL, place in a 10 mL measuring bottle, dilute to the mark with diluent [methanol-water-glacial acetic acid (65:35:0.2)], shake well, and use as Reference substance solution;

[0069] (3) Preparation of the test solution: Take an appropriate amount of mometasone furoate cre...

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Abstract

The invention provides a content determination method of mometasone furoate cream, and relates to the technical field of chemical detection. The content determination method comprises the following steps: preparing a beclomethasone propionate internal standard solution; preparing a mometasone furoate reference substance solution; preparing a mometasone furoate cream test solution; and measuring the content by an internal standard method. By improving the previous detection standard and resetting the detection conditions, the problems of leading peak pattern and poor symmetry of the main peak in the existing standard content determination method are effectively solved, so that the content detection of the mometasone furoate cream is more accurate and reliable.

Description

technical field [0001] The invention belongs to the technical field of chemical detection, and relates to a method for determining the content of mometasone furoate cream. Background technique [0002] Mometasone furoate is a synthetic corticosteroid hormone drug, which has anti-inflammatory, anti-allergic, anti-itching and reducing exudation effects, and can eliminate fever, redness and swelling symptoms caused by local inflammatory reactions. It is clinically applicable to various diseases that are effective for corticosteroid therapy, such as acute urticaria, neurodermatitis, seborrheic dermatitis, allergic dermatitis, chronic eczema, insect bite dermatitis, systemic lupus erythematosus, pemphigus, etc. The pre-market testing of drugs is often carried out from the aspects of drug properties, identification, inspection, and content determination. [0003] For the content detection of medicines, Li Wei et al. proposed a method for determining the content of mometasone furo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88A61K9/06A61K31/58A61K47/06A61K47/10A61P5/44A61P17/00A61P17/04A61P37/08
CPCG01N30/88A61K31/58A61K9/06A61K47/10A61K47/06A61P5/44A61P17/04A61P37/08A61P17/00G01N2030/884
Inventor 朱岁华黄芷茵周洁陈溪高燕王智森唐九歌陈贤安
Owner GUANGZHOU BAIYUNSHAN PHARM CO LTD
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