Method for detecting related substances in ketoconazole sample and method for preparing ketoconazole preparation

A related substance, ketoconazole technology, applied in the field of medicine, can solve problems to be improved, etc.

Inactive Publication Date: 2016-10-12
HUBEI HUMANWELL CHENGTIAN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] However, the current method for the detection of relate

Method used

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  • Method for detecting related substances in ketoconazole sample and method for preparing ketoconazole preparation
  • Method for detecting related substances in ketoconazole sample and method for preparing ketoconazole preparation
  • Method for detecting related substances in ketoconazole sample and method for preparing ketoconazole preparation

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Experimental program
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Effect test

Embodiment 1

[0060] In this embodiment, 10 microliters of the system suitability solution was taken according to the method and conditions basically the same as the general method, and injected into a high performance liquid chromatograph to detect the system suitability solution. The difference is that the mobile phase ratio used in this embodiment carries out gradient elution according to the following conditions:

[0061]

[0062] The chromatogram that this embodiment detects obtains is as figure 1 shown. Depend on figure 1 It can be seen that the retention time of the ketoconazole peak is 5.760 minutes, the retention time of the loperamide hydrochloride peak is 8.930 minutes, and the degree of separation of the two is 19.852, which basically meets the retention time of the ketoconazole peak as 6 minutes, two The detection standard of "Chinese Pharmacopoeia" with a peak resolution greater than 15.

Embodiment 2

[0064] In this embodiment, 10 microliters of the system suitability solution was taken according to the method and conditions basically the same as the general method, and injected into a high performance liquid chromatograph to detect the system suitability solution. The difference is that the mobile phase ratio used in this embodiment carries out gradient elution according to the following conditions:

[0065]

[0066]

[0067] The chromatogram that this embodiment detects obtains is as figure 2 shown. Depend on figure 2 It can be seen that the retention time of the ketoconazole peak is 6.057 minutes, the retention time of the loperamide hydrochloride peak is 9.123 minutes, and the degree of separation between the two is 19.513, which fully meets the retention time of the ketoconazole peak and is 6 minutes, two The detection standard of "Chinese Pharmacopoeia" with a peak resolution greater than 15.

Embodiment 3

[0069] In this embodiment, 10 microliters of the system suitability solution was taken according to the method and conditions basically the same as the general method, and injected into a high-performance liquid chromatograph to detect the system suitability solution. The difference is that the mobile phase ratio used in this embodiment carries out gradient elution according to the following conditions:

[0070]

[0071] The chromatogram that this embodiment detects obtains is as image 3 shown. Depend on image 3 It can be seen that the retention time of the ketoconazole peak is 6.337 minutes, the retention time of the loperamide hydrochloride peak is 9.317 minutes, and the degree of separation of the two is 18.885, which basically meets the retention time of the ketoconazole peak as 6 minutes, two The detection standard of "Chinese Pharmacopoeia" with a peak resolution greater than 15.

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Abstract

The invention provides a method for detecting related substances in a ketoconazole sample, a method for preparing compound ketoconazole cream or compound ketoconazole hair lotion and a preparation containing ketoconazole. The method for detecting the related substances in the ketoconazole sample comprises steps as follows: the related substances in the ketoconazole sample are detected with HPLC (high-performance liquid chromatography), loperamide hydrochloride is adopted as a reference substance, a flowing phase A is a tetrabutylammonium hydrogen sulfate solution with the concentration being 0.34w/v%, and a flowing phase B is acetonitrile. With the adoption of the detection method, the related substances in the ketoconazole sample can be effectively detected.

Description

technical field [0001] The present invention relates to the field of medicine. Specifically, the present invention relates to a method for detecting related substances in ketoconazole samples, a method for preparing compound ketoconazole ointment or compound ketoconazole hair lotion, and compound ketoconazole ointment or compound ketoconazole hair lotion prepared by the method. Use lotion. Background technique [0002] Compound ketoconazole ointment is suitable for the treatment of tinea corporis, tinea manus, pedis and jock itch. Compound ketoconazole hair lotion is indicated for the treatment of infections caused by various fungi, such as scalp pityriasis, seborrheic dermatitis and tinea versicolor. The main ingredients of these two drugs are ketoconazole and clobetasol propionate, but the content of clobetasol propionate is slightly different. [0003] Ketoconazole, as an imidazole antifungal ingredient, has a good therapeutic effect on systemic chronic various mycoses...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 刘长国罗光明张甫李丽琴李瑾芳闫宏波
Owner HUBEI HUMANWELL CHENGTIAN PHARMA
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