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A method for analyzing the content of adrenocortical hormone fluorometholone and related substances

A technology of adrenal cortex and related substances, which is applied to the analysis of materials, measuring devices, and material separation, can solve the problems of poor chromatographic peak shape, high flow rate, high column pressure, etc., and achieve simple and convenient operation process, accurate detection results, highly feasible effect

Active Publication Date: 2020-04-03
TIANJIN PHARMACN MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

There are many problems in the detection of fluorometholone content and related substances included in USP37 and BP2011, such as some impurities cannot be detected; the separation between some chromatographic peaks cannot meet the requirements of the Pharmacopoeia, and some chromatographic peaks have poor peak shapes , the flow rate is relatively large, the column pressure is too high, and the chromatographic column is easy to wear out

Method used

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  • A method for analyzing the content of adrenocortical hormone fluorometholone and related substances
  • A method for analyzing the content of adrenocortical hormone fluorometholone and related substances
  • A method for analyzing the content of adrenocortical hormone fluorometholone and related substances

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] 1. Chromatographic conditions:

[0043] High performance liquid chromatography: Agilent 1260HPLC

[0044] Chromatographic column: ZORBAX SB-C18, 250*4.6mm, 5μm

[0045] Detector: UV detector Detection wavelength: 235nm

[0046] Injection volume: 10μl Column temperature: 35℃

[0047] Flow rate: 1.0ml / min

[0048] Analytical balance: ten thousandth

[0049] Mobile Phase: A: Water B: Acetonitrile

[0050] 2. The gradient conditions are as follows:

[0051]

[0052] 3. Test results: as shown in Table 1 below.

[0053] Table 1

[0054]

[0055]

[0056] The separation between fluorometholone and the front and back impurities is greater than 2.0, and the separation between other peaks is greater than 1.5;

[0057] figure 1 It is the liquid phase spectrogram of embodiment 1 of the present invention.

Embodiment 2

[0059] 1. Chromatographic conditions:

[0060] High performance liquid chromatography: Agilent 1260HPLC

[0061] Chromatographic column: ZORBAX SB-C18, 250*4.6mm, 5μm

[0062] Detector: UV detector Detection wavelength: 254nm

[0063] Injection volume: 10μl Column temperature: 30℃

[0064] Flow rate: 1.2ml / min

[0065] Analytical balance: ten thousandth

[0066] Mobile Phase: A: Water B: Acetonitrile

[0067] 2. The gradient conditions are the same as those in Example 1.

[0068] 3. Test results: as shown in Table 2 below.

[0069] Table 2

[0070]

[0071]

[0072]The separation between fluorometholone and impurities after the main peak is less than 2.0, and the separation between other peaks is greater than 1.5.

Embodiment 3

[0074] 1. Chromatographic conditions:

[0075] High performance liquid chromatography: Agilent 1260HPLC

[0076] Chromatographic column: ZORBAX SB-C18, 250*4.6mm, 5μm

[0077] Detector: UV detector Detection wavelength: 254nm

[0078] Injection volume: 10μl Column temperature: 25℃

[0079] Flow rate: 2.0ml / min

[0080] Analytical balance: ten thousandth

[0081] Mobile Phase: A: Water B: Acetonitrile

[0082] 2. The gradient conditions are the same as those in Example 1.

[0083] 3. Test results: The relevant data are listed in Table 3 below.

[0084] table 3

[0085]

[0086]

[0087] The separation between fluorometholone and impurities after the main peak is less than 2.0, and the separation between other peaks is greater than 1.5.

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Abstract

The invention belongs to the field of medicine analyzing methods and particularly relates to a method for analyzing adrenocortical hormone fluorometholone content and related substances. The method includes: using a high performance liquid chromatograph and a ZORBAX SB-C18 chromatographic column; using an ultraviolet detector for detection; performing gradient elution according to the following table as shown in the specification, wherein the detection wavelength is 235-254 nanometers, the flow speed is 1.0-2.0ml / minute, the flowing phase comprises a flow phase A and a flow phase B, the flow phase A is water and the flow phase B is acetonitrile or ethanol. The method has the advantages that methodology validation is performed on the the analyzing conditions above according the 'chemical drug quality control analyzing method validation technical guidance principles' ([H]-GPH5-1) issued by the State Food and Drug Administration, and the result proves that the method is practical, reliable, good in stability and capable of satisfying the detecting requirements of the fluorometholone content and related substances.

Description

technical field [0001] The invention belongs to the field of drug analysis methods, in particular to an analysis method for the content of adrenocortical hormone fluorometholone and related substances. Background technique [0002] At present, liquid chromatography is one of the most widely used analysis methods in modern chromatographic technology, and it is widely used in many fields such as chemical industry, environment, biochemistry, food, agriculture, and medicine. [0003] Fluorometholone is a specific drug for the treatment of glucocorticoid-sensitive eyelid bulbar conjunctiva, cornea and other anterior tissue inflammation; the anti-inflammatory effect of fluorometholone is 40 times that of hydrocortisone, and topical application has anti-inflammatory effects , vasoconstriction and antipruritic effect. Its structure is as follows: [0004] [0005] At present, there are reports on the analysis methods of fluorometholone in various pharmacopoeias. Among them, the...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 田东奎何磊
Owner TIANJIN PHARMACN MEDICAL TECH
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