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Detection method for Captopril related substance

A detection method and technology of related substances, applied in the field of detection of related substances of captopril, can solve problems such as inability to fully separate peaks, and achieve sufficient separation effect

Active Publication Date: 2019-08-20
HUNAN HANSEN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] However, none of the analytical methods currently provided can sufficiently separate each related substance or related substances from the peaks of captopril. Therefore, it is of great significance to provide a detection method for related substances of captopril.

Method used

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  • Detection method for Captopril related substance
  • Detection method for Captopril related substance
  • Detection method for Captopril related substance

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] Method exploration process, the specific exploration plan is shown in Table 3

[0073] table 3

[0074]

[0075]

[0076]

[0077]

[0078] See the HPLC color diagram corresponding to methods 1-9 in the table Figure 1~Figure 9 , figure 1 Is the high performance liquid chromatogram of Method 1 in Example 1, figure 2 Is the high performance liquid chromatogram of Method 2 in Example 1, image 3 Is the high performance liquid chromatogram of Method 3 in Example 1, Figure 4 Is the high performance liquid chromatogram of Method 4 in Example 1, Figure 5 Is the high performance liquid chromatogram of Method 52 in Example 1, Image 6 Is the high performance liquid chromatogram of Method 6 in Example 1, Figure 7 Is the high performance liquid chromatogram of Method 7 in Example 1, Figure 8 Is the high performance liquid chromatogram of Method 8 in Example 1, Picture 9 This is the high performance liquid chromatogram of Method 9 in Example 1.

Embodiment 2

[0080] 1) Confirmation of related substances method

[0081] (1) Mobile phase A: Take 1.563g of sodium dihydrogen phosphate, add 950ml of water to dissolve, adjust the pH to 2.2 with phosphoric acid, add water to 1000ml, shake well, filter, and get it;

[0082] (2) Mobile phase B: mobile phase A-acetonitrile (50:50);

[0083] (3) Chromatographic column: Agilent ZORBAX SB-Aq (4.6*250mm, 5μm);

[0084] Install ghost peak trapping small column (Welch Ghost-buster 4.6*50mm, 5μm);

[0085] The flow rate is 1.0ml / min, the wavelength is 210nm, the column temperature is 50°C, and the injection volume is 20μl;

[0086] The gradient elution is shown in Table 4:

[0087] Table 4

[0088]

[0089]

[0090] Preparation of the test solution: accurately weigh an appropriate amount of fine powder of this product (approximately 25mg of captopril), put it in a 10ml measuring flask, and add a diluent solvent [0.01mol / L sodium dihydrogen phosphate solution (adjusted with phosphoric acid) pH value to 2.2)-ace...

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Abstract

The invention provides a detection method for a Captopril related substance. According to the method, an appropriate liquid chromatogram detection condition is selected. Results show that the method can be used to fully separate Captopril from a known related compound.

Description

Technical field [0001] The invention relates to the technical field of drug analysis, in particular to a detection method of captopril related substances. Background technique [0002] Related substances are the starting materials, intermediates, side reaction products and degradation impurities brought in during the synthesis and production of drugs. The detection of related substances can control the quality and safety of drugs. [0003] Captopril is the first angiotensin-converting enzyme inhibitor (ACEI) discovered in the 1990s. Since its appearance in the 1990s, it has shifted from a special drug for the treatment of high blood pressure to the treatment of other cardiovascular diseases, rheumatoid arthritis and other diseases. The development of clinical drugs has great clinical value. Captopril will also have many related substances in the process of preparation and storage. For details of captopril and impurities (impurity numbers are consistent with those in the British Pha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/36
CPCG01N30/02G01N30/36
Inventor 刘令安杨华熊映红王西凤高慧娟
Owner HUNAN HANSEN PHARMACEUTICAL CO LTD
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