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Method for separation and determination of two medicine contents and related substances in tazarotene-betamethasone cream

A technology of tazarotene and betamethasone, applied in the field of analytical chemistry, to achieve accurate, reliable and repeatable results

Active Publication Date: 2017-07-04
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

So far, there is no published method reported to effectively separate and quantify the two drugs and their related substances in tazarotene betamethasone cream

Method used

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  • Method for separation and determination of two medicine contents and related substances in tazarotene-betamethasone cream
  • Method for separation and determination of two medicine contents and related substances in tazarotene-betamethasone cream
  • Method for separation and determination of two medicine contents and related substances in tazarotene-betamethasone cream

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Example 1 Method for Separating and Determining Related Substances in Tazarotene Betamethasone Cream

[0048] Instrument: SHIMADZU LC-20A (Shimadzu, Japan)

[0049] Chromatographic column: VP-ODS 4.6×250mm 5μm

[0050] Mobile phase A: 0.1% trifluoroacetic acid solution-methanol (95:5)

[0051] Mobile Phase B: Acetonitrile

[0052] Flow rate: 1.0ml / min

[0053] Detector: UV

[0054] Detection wavelength: 250nm

[0055] Injection volume: 20μl

[0056] Chromatography Workstation: LabSolution

[0057] Linear gradient elution program:

[0058]

[0059]Sample preparation: Take about 5g of this product, accurately add 25ml of acetonitrile, heat in a water bath at 50°C, stir to melt and disperse the paste, continue to stir for 2 minutes, take it out, transfer it to a 50ml centrifuge tube with stopper while it is hot, and place it on ice Cool in a water bath for more than 30 minutes, centrifuge to separate the layers, take the supernatant and filter it quickly, take t...

Embodiment 2

[0060] Embodiment 2 The method for separating and measuring the content of two kinds of drugs in tazarotene betamethasone cream

[0061] Instrument: SHIMADZU LC-20A (Shimadzu, Japan)

[0062] Chromatographic column: VP-ODS 4.6×250mm 5μm

[0063] Mobile phase A: 0.1% trifluoroacetic acid solution-methanol (95:5)

[0064] Mobile Phase B: Acetonitrile

[0065] Flow rate: 1.0ml / min

[0066] Detector: UV

[0067] Detection wavelength: 250nm

[0068] Injection volume: 20μl

[0069] Chromatography Workstation: LabSolution

[0070] Linear gradient elution program:

[0071]

[0072] Sample preparation: Take 2.0g of this product (approximately equivalent to 1mg of tazarotene and 1mg of betamethasone), weigh it accurately, put it in a 50ml brown measuring bottle, add 25ml of acetonitrile, heat it in a water bath at 50°C, and shake to make the main Dissolve the drug, let it cool to room temperature, and dilute to the mark with acetonitrile, shake well, filter, accurately measur...

Embodiment 3

[0073] Embodiment 3 sample detection result

[0074] According to the methods of Example 1 and Example 2, the related substances and contents of multiple batches of tazarotene betamethasone cream were detected.

[0075] Table 8 Test results of related substances in tazarotene betamethasone cream

[0076] batch number Betamethasone 17-propionate, % Betamethasone 21-propionate, % Tazarotene sulfoxide, % 2010003 0.10 0.22 0.44 2010004 0.13 0.24 0.46 2010005 0.14 0.23 0.48 20130601 0.07 0.35 0.25 20130602 0.07 0.33 0.28 20130603 0.07 0.26 0.25

[0077] Table 9 Tazarotene betamethasone cream content test results

[0078] batch number Betamethasone dipropionate (calculated as betamethasone), % Tazarotene, % 2010003 100.5 100.6 2010004 99.9 100.3 2010005 97.9 99.9 20130601 98.2 97.0 20130602 97.8 96.6 20130603 99.6 96.8

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Abstract

The present invention belongs to the field of analytical chemistry, and relates to a method for separation and determination of two medicine contents and related substances in a tazarotene-betamethasone cream. According to the method, a reagent composition for solid-liquid separation and determination of two medicine contents and related substances in a tazarotene-betamethasone cream comprises an acidic aqueous solution system and acetonitrile, wherein the acidic aqueous solution system comprises an acidic additive, methanol and water; and by using the reagent composition, the two medicine contents and the related substances in the tazarotene-betamethasone cream can be simultaneously separated and determined through high performance liquid chromatography. According to the present invention, the method has good reproducibility, the solvent peak does not interfere with the determination of the two medicine contents and the related substances in the tazarotene-betamethasone cream during the detection, the two medicines and the related substances in the tazarotene-betamethasone cream can be effectively separated, the separation degree is more than 2.0, the detection result is accurate and reliable, and the important significance is provided for the achievement of the quality control of the tazarotene-betamethasone cream.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a method for separating and measuring the contents of two drugs and related substances in tazarotene betamethasone cream. Background technique [0002] Tazarotene-betamethasone cream is a compound preparation for treating psoriasis, containing tazarotene and betamethasone dipropionate, which is composed of 0.05% tazarotene and 0.05% betamethasone dipropionate ( A brand-new compound preparation composed of betamethasone), mainly used for the treatment of psoriasis vulgaris. [0003] Tazarotene is the third-generation retinoic acid drug, which has special effects on plaque psoriasis vulgaris. After tazarotene is administered, it quickly degreases in the body and converts it into the active ingredient tazarotene acid, which is selective. Binding to retinoic acid receptors, targeting diseased tissues, regulating cell differentiation, anti-proliferation, and anti-infla...

Claims

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Application Information

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IPC IPC(8): G01N30/89
CPCG01N30/89
Inventor 杨平
Owner CHONGQING HUAPONT PHARMA
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