Method for detecting beclomethasone propionate related substances

A technology for beclomethasone propionate and related substances, which is applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve the problems of poor separation, control, inability to accurately quantify, etc.

Active Publication Date: 2020-04-14
SICHUAN PURITY PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The Chinese Pharmacopoeia 2015 edition, USP41, EP9.0 recorded the quality standard of "Beclomethasone Dipropionate Raw Materials". The Chinese Pharmacopoeia 2015 edition and USP41 related substances all used thin-layer chromatography, which could not be accurately quantified, and EP9.0 used HPLC method , but the resolution of impurity D and the main peak is poor, and the main active metabolite impurity H (beclomethasone 17-monopropionate) is not controlled

Method used

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  • Method for detecting beclomethasone propionate related substances
  • Method for detecting beclomethasone propionate related substances
  • Method for detecting beclomethasone propionate related substances

Examples

Experimental program
Comparison scheme
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Embodiment 1

[0058] Embodiment 1: Change chromatographic column on the basis of comparative example 2 chromatographic conditions

[0059]

[0060] see results image 3 : The resolution of impurity H and impurity A increases, and the other peaks achieve baseline separation. Therefore, the final optimal chromatographic conditions are:

[0061]

[0062] In the solution of the present invention, column temperature, detection wavelength, sample volume, flow rate, etc. can be selected within common ranges. The detection wavelength can be adjusted and selected by conventional means within the range disclosed above. When looking for the best detection wavelength, you can use ultraviolet spectrophotometry, HPLC supporting full-band scanning and other methods, and then cooperate with the detection effect of the HPLC detector (such as avoiding solvent interference, etc.), and use conventional techniques to find the appropriate detection wavelength. . The above embodiments are the preferred ...

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Abstract

The invention provides a method for detecting beclomethasone propionate related substances. The method optimizes the separation degree of an impurity D and a main peak of beclomethasone propionate through liquid chromatography, and detects the main metabolite (impurity H), and is beneficial to the quality control of beclomethasone propionate and the improvement of dosing accuracy.

Description

technical field [0001] The invention belongs to the field of drug quality control, in particular to a detection and quantitative control method for related substances of beclomethasone dipropionate. Background technique [0002] Beclomethasone dipropionate has the following molecular formula: [0003] [0004] It is a powerful topical glucocorticoid drug with anti-inflammatory, anti-allergic and antipruritic effects. It can inhibit bronchial exudate, eliminate bronchial mucosal swelling, and relieve bronchospasm. It has a stronger effect on skin vasoconstriction than hydrocortisone. The local anti-inflammatory effect is 5 times that of Fucaolin and Triamcinolone. Strong lipophilicity, easy to penetrate, it will take effect 30 minutes after applying to the affected area. External application can treat various inflammatory skin diseases, such as eczema, allergic dermatitis, neurodermatitis, contact dermatitis, psoriasis, itching, etc. Aerosol can be used for chronic and...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 吴林朱柯武李丛菊杨丽韩佳许小军侯曙光吴君
Owner SICHUAN PURITY PHARM CO LTD
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