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Detection method of methylprednisolone sodium succinate freeze-dried powder injection related substance

A technology of methylprednisolone sodium succinate and freeze-dried powder injection, which is applied in the detection field of methylprednisolone sodium succinate freeze-dried powder injection, and can solve the problems of inability to effectively separate impurities, unsuitable detection substances, and unpublished quality detection methods, etc. question

Inactive Publication Date: 2012-01-18
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent CN200610076703.8 provides a methylprednisolone sodium succinate freeze-dried powder injection, but does not disclose its quality testing method, and the current national drug standard WS about methylprednisolone sodium succinate for injection 1 -(X-520)-2003Z only stipulates the method of using the internal standard method to detect the content and free methylprednisolone, and does not stipulate the detection method for related substances. , the establishment of standards and testing methods for related substances has become an urgent need to improve and better control the quality of methylprednisolone sodium succinate freeze-dried powder injection
However, after our experiments, we found that the current content and free methylprednisolone detection methods cannot effectively separate all impurities, and are not suitable for the detection of related substances

Method used

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  • Detection method of methylprednisolone sodium succinate freeze-dried powder injection related substance
  • Detection method of methylprednisolone sodium succinate freeze-dried powder injection related substance

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Existing HPLC conditions for detecting content and free methylprednisolone content are used to detect related substances, and normalization method is used without internal standard substance.

[0034] The detection method is as follows

[0035] Chromatographic conditions Chlorobutane-water saturated chlorobutane-tetrahydrofuran-methanol-glacial acetic acid (475:475:70:35:30) is the mobile phase; the detection wavelength is 254nm.

[0036] Preparation of Determination Method Reference Substance Solution Accurately weigh an appropriate amount of methylprednisolone succinate (about 15.84mg), put it in a 50ml measuring bottle, add 5ml of tetrahydrofuran, add 3% glacial acetic acid chloroform to dissolve and dilute to the scale, shake well, and accurately measure Take 1ml, put it in a 100ml measuring bottle, add 3% glacial acetic acid chloroform solution to dilute to the mark, shake well, and you get it.

[0037] Preparation of the test solution Precisely weigh an appropria...

Embodiment 2

[0041] Adopt the method provided by the invention to carry out related substance content detection

[0042] The content of relevant substances adopts the following methods:

[0043] Chromatographic conditions The mobile phase is n-chlorobutane-water saturated n-chlorobutane-tetrahydrofuran-methanol-glacial acetic acid with a volume ratio of 130:130:14:7:6; the detection wavelength is 254nm.

[0044] Preparation of reference solution Accurately weigh an appropriate amount of methylprednisolone succinate (about 15.84mg), put it in a 50ml measuring bottle, add 5ml of tetrahydrofuran, add 3% glacial acetic acid chloroform to dissolve and dilute to the mark, shake well, and accurately measure 1ml , put it in a 100ml measuring bottle, add 3% glacial acetic acid chloroform solution to dilute to the mark, shake well, and you get it.

[0045] Preparation of the test solution Precisely weigh an appropriate amount of the test (approximately equivalent to 0.25g of methylprednisolone), pu...

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Abstract

A detection method of methylprednisolone sodium succinate freeze-dried powder injection related substances adopts a high performance liquid chromatography method, and is characterized in that the chromatographic conditions are that: silica gel is selected as a stationary phase of a chromatographic column; n-butyl chloride - water-saturated n-butyl chloride - tetrahydrofuran - methanol - glacial acetic acid with a volume ratio of 130:130:14:7:6 is selected as a mobile phase; and the detection wavelength is 254 nm.

Description

Technical field: [0001] The invention relates to a method for detecting methylprednisolone sodium succinate freeze-dried powder injection, in particular to a method for detecting related substances in methylprednisolone sodium succinate freeze-dried powder injection. Background technique: [0002] Methylprednisolone has anti-inflammatory, anti-allergic, anti-rheumatic, and immunosuppressive effects, and is widely used in the treatment of allergic and autoimmune inflammatory diseases, such as connective tissue diseases, active rheumatism, rheumatoid arthritis, erythema Lupus, severe bronchial asthma, severe dermatitis, ulcerative colitis, acute leukemia, etc., are also used in the comprehensive treatment of certain severe infections, poisoning, and malignant lymphoma. Because it is an insoluble organic compound, it can be prepared as a water-soluble salt, such as methylprednisolone sodium succinate, for the convenience of preparing an injection. Chinese patent CN200610076703...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/28G01N30/74
Inventor 何光杰张宝文袁英吴俊文
Owner TIANJIN JINYAO GRP
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