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Identification method of sertaconazole nitrate cream

A technology of sertaconazole nitrate and cream, applied in the field of medicine, can solve the problem of difficult to achieve high-efficiency and stable identification of sertaconazole nitrate cream product quality, can not effectively control the quality of sertaconazole nitrate cream formulation, unfavorable Sertaconazole nitrate cream is safe and widely used to achieve the effects of shortened activation time, stable separation, and moderate Rf value

Pending Publication Date: 2021-04-02
HAINAN HAISHEN TONGZHOU PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And in the preparation technology of sertaconazole nitrate and cream dosage form, usually continue to use the identification method of sertaconazole nitrate medicine to carry out the differentiation of sertaconazole nitrate cream product, but existing sertaconazole nitrate The identification method cannot effectively control the quality of the sertaconazole nitrate cream formulation, and due to the influence of the sertaconazole nitrate cream formulation, it is difficult to achieve efficient and stable identification of the quality of the sertaconazole nitrate cream product, which is not conducive to control Production and quality assurance of sertaconazole nitrate cream as well as clinical safety and wide application

Method used

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  • Identification method of sertaconazole nitrate cream

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] The identification method of sertaconazole nitrate cream: including the following steps:

[0029] (1) Preparation of the test solution: take 10 groups of sertaconazole nitrate cream samples of 16mg each, add 20ml of absolute ethanol, place in a 65°C water bath to heat and dissolve, cool, centrifuge at 2000r / min for 3min, and take The supernatant is used as the test solution;

[0030] (2) Preparation of reference substance solution: take sertaconazole nitrate reference substance, the purity of sertaconazole nitrate is >99.5%, add absolute ethanol to dissolve, dilute to make sertaconazole nitrate with a mass concentration of 0.8mg / ml solution, as a reference substance solution;

[0031] (3) Prepare developer: use chloroform, n-hexane, methanol and concentrated ammonia solution to mix according to the mass ratio of 45:40:15:1 to obtain developer 1; use n-octanol, ethyl acetate: acetone 60 : 20:5 mixed to obtain developer 2;

[0032] (4) Chromatographic conditions and op...

Embodiment 2

[0034] The identification method of sertaconazole nitrate cream: including the following steps:

[0035] (1) Preparation of the test solution: take 10 groups of sertaconazole nitrate cream samples of 30 mg each, add 25 ml of absolute ethanol, heat and dissolve in a water bath at 75 ° C, cool, centrifuge at 3000 r / min for 5 min, and take The clear liquid is used as the test solution;

[0036] (2) Prepare reference substance solution: get sertaconazole nitrate reference substance, add absolute ethanol to dissolve, dilute and make mass concentration be the sertaconazole nitrate solution of 1.2mg / ml, as reference substance solution;

[0037] (3) Prepare developer: use chloroform, n-hexane, methanol and concentrated ammonia solution to mix according to the mass ratio of 55:60:25:3 to obtain developer 1; use n-octanol, ethyl acetate: acetone 70 :30:15 mixed to obtain developing agent 2;

[0038] (4) Chromatographic conditions and operation: according to thin-layer chromatography, ...

Embodiment 3

[0040] The identification method of sertaconazole nitrate cream: including the following steps:

[0041](1) Preparation of the test solution: take 20 mg of each of 10 groups of sertaconazole nitrate cream samples, add 20 ml of absolute ethanol, heat and dissolve in a water bath at 60 ° C, cool, centrifuge at 2500 r / min for 4 min, and take the The clear liquid is used as the test solution;

[0042] (2) Preparation of reference substance solution: take sertaconazole nitrate reference substance, add absolute ethanol to dissolve, dilute and make a sertaconazole nitrate solution with a mass concentration of 1.0 mg / ml, as the reference substance solution;

[0043] (3) Prepare developing agent: use chloroform, n-hexane, methanol and concentrated ammonia solution to mix according to the mass ratio of 50:50:20:2 to obtain developing agent 1; use n-octanol, ethyl acetate: acetone 65 :25:10 mixed to obtain developer 2;

[0044] (4) Chromatographic conditions and operation: according to...

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Abstract

The invention provides an identification method of sertaconazole nitrate cream, which comprises the following steps: (1) taking a sertaconazole nitrate cream sample, adding absolute ethyl alcohol, heating to dissolve in a water bath, centrifuging, and taking supernatant as a test solution; (2) taking a sertaconazole nitrate reference substance, adding absolute ethyl alcohol for dissolving, and diluting to obtain a reference substance solution; (3) mixing trichloromethane, n-hexane, methanol and a concentrated ammonia solution to obtain a developing solvent 1, and mixing n-octyl alcohol, ethylacetate and acetone to form a developing solvent 2; and (4) respectively dripping 1-2 microliters of the two solutions on the same silica gel GF254 thin-layer plate, sequentially putting the silica gel GF254 thin-layer plate into a developing solvent 1 and a developing solvent 2 for developing, airing, and inspecting under an ultraviolet lamp 254nm. The identification method can shorten the activation time of the silica gel GF254 thin-layer plate, and has the advantages of obvious and clear spots, stable separation, no tailing and moderate Rf value, and the method has good repeatability and stability for thin-layer chromatography identification of the sertaconazole nitrate emulsifiable paste.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for identifying sertaconazole nitrate cream. Background technique [0002] Sertaconazole nitrate is a new type, broad-spectrum, high-efficiency topical antifungal agent, which was developed by the Spanish company Ferrer. Compared with other clinical imidazole antibacterial agents, it is more effective against pathogens causing skin and mucous membrane infections, pathogenic yeasts, skin fungi, opportunistic pathogens, filamentous fungi, Gram-positive bacteria and Trichomonas spp. All have antibacterial activity, so have a wider range of safety. [0003] Sertaconazole nitrate cream is an existing common dosage form. It mainly combines the main drug with emulsifiers, moisturizers, stabilizers and other auxiliary materials to achieve good stability of sertaconazole nitrate cream. Ensure its full dispersion and emulsification, reduce demulsification, delamination and othe...

Claims

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Application Information

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IPC IPC(8): G01N30/90G01N30/94G01N30/95
CPCG01N30/90G01N30/94G01N30/95
Inventor 韦家华刘玉
Owner HAINAN HAISHEN TONGZHOU PHARM CO LTD
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