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Method for detecting fudosteine and impurities and enantiomers in fudosteine tablet

A technology for enantiomers and fudosteine ​​tablets, which is applied in the field of detection of impurity A, impurity B and dextro-isomer in fudosteine ​​and fudosteine ​​tablets, and can solve the problem of easily interfering with other impurities, Problems such as different retention times

Active Publication Date: 2021-06-01
JIANGSU CHIA TAI FENGHAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Impurity A and impurity B are degradation impurities produced by the oxidation of fudosteine, wherein impurity A has diastereoisomers, and different configurations may have different retention times (two peaks), and are likely to interfere with other impurities; fudosteine Contains a chiral center, the dextroisomer of fudosteine ​​may be produced during the process

Method used

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  • Method for detecting fudosteine and impurities and enantiomers in fudosteine tablet
  • Method for detecting fudosteine and impurities and enantiomers in fudosteine tablet
  • Method for detecting fudosteine and impurities and enantiomers in fudosteine tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0099] Example 1 Detection of Impurity A, Impurity B and Enantiomers in Fudosteine ​​Raw Materials

[0100] Instrument and equipment samples:

[0101] High performance liquid chromatography: Ultimate3000

[0102] Analytical balance: Mettler Toledo XP205

[0103] pH meter: Mettler Toledo S20

[0104] Fudosteine ​​samples: 1901001, 1901002, 1901003, produced by Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd.

[0105] Chromatographic conditions:

[0106] Chromatographic column: Silica gel coated with chiral crown ether is used as filler;

[0107] Mobile phase: use pH1.5 perchloric acid solution as the mobile phase;

[0108] Flow rate: 0.25ml / min;

[0109] Column temperature: 12°C;

[0110] Detector: UV detector, the detection wavelength is 210nm.

[0111] Detection steps:

[0112] (1) Take about 300mg of fudosteine ​​raw material, accurately weigh it, put it in a 10ml measuring bottle, add mobile phase to dissolve and dilute to the mark, shake well, centrifuge, and take...

Embodiment 2

[0127] The detection of impurity A, impurity B and enantiomer in the fodosteine ​​raw material of embodiment 2

[0128] With reference to the equipment, chromatographic conditions and detection steps in Example 1, only the sample batch number is changed to 1906001, 1906002, 1906003, the mobile phase is changed to pH1.2 perchloric acid solution in the chromatographic conditions, the flow rate is changed to 0.20ml / min, and the column Change the temperature to 15°C.

[0129] Test results: Calculated by the peak area according to the external standard method, the contents of impurity A, impurity B and dextro isomer in the three batches of samples are all no more than 0.1%, all complying with the regulations ( image 3 , Figure 4 , Table 13).

[0130] Table 13 Example 2 detection results

[0131]

[0132] Note: the calculation formula is the same as in Example 1.

Embodiment 3

[0133] Example 3 Detection of Impurity A, Impurity B and Enantiomers in Fudosteine ​​Tablets

[0134] Instrument and equipment samples:

[0135] High performance liquid chromatography: Ultimate3000

[0136] Analytical balance: Mettler Toledo XP205

[0137] pH meter: Mettler Toledo S20

[0138] Samples of fudosteine ​​tablets: 1704151, 1710251, 1710261, produced by Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd.

[0139] Chromatographic conditions:

[0140] Chromatographic column: silica gel coated with chiral crown ether is used as filler;

[0141] Mobile phase: use pH1.5 perchloric acid solution as the mobile phase;

[0142] Flow rate: 0.25ml / min;

[0143] Column temperature: 10°C;

[0144] Detector: UV detector, the detection wavelength is 210nm.

[0145] Detection steps:

[0146] (1) Take fudosteine ​​tablet and grind it into fine powder, take an appropriate amount (approximately equivalent to fudosteine ​​200mg), weigh it accurately, put it in a 10ml measuring bott...

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Abstract

The invention provides a method for detecting fudosteine and impurities and enantiomers in a fudosteine tablet by liquid chromatography. The method comprises the following steps: adopting silica gel coated with chiral crown ether as a filler; using a perchloric acid solution as a mobile phase; and calculating the contents of the impurity A, the impurity B and the enantiomer in the fudosteine and the fudosteine tablet by an external standard method. The method is simple and rapid, can be used for detecting the fudosteine and the enantiomer in the fudosteine tablet, and also can be used for detecting the impurity A and the impurity B at the same time, so that the analysis efficiency is improved.

Description

technical field [0001] The invention relates to an analysis method for detecting impurity A, impurity B and dextro-isomer in fudosteine ​​and fudosteine ​​tablets by liquid chromatography. Background technique [0002] Fudosteine ​​is a class of cysteine ​​derivatives with an expectorant effect with the basic skeleton of steine, and has multiple pharmacological effects on chronic respiratory diseases. Fudosteine ​​tablets are prepared for it . Impurity A and impurity B are degradation impurities produced by the oxidation of fudosteine, wherein impurity A has diastereoisomers, and different configurations may have different retention times (two peaks), and are likely to interfere with other impurities; fudosteine Contains a chiral center, the dextroisomer of fudosteine ​​may be produced during the process. In summary, we need to provide a method to control the above impurities. [0003] For the detection of fudosteine ​​isomers in the prior art, there are reports of pre-co...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/56G01N30/74
CPCG01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/56G01N30/74G01N2030/324G01N2030/562
Inventor 朱琳杜柳辉马利华李婷叶海英朱永强
Owner JIANGSU CHIA TAI FENGHAI PHARMA
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