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Method for measuring fudosteine related substance by using amino column

A technology for related substances and determination methods, which is applied in the field of determination of related substances of fudosteine ​​by using an amino column, can solve the problems of difficult impurities to be separated, poor repeatability of measurement results, large damage to fillers, etc., and achieve good durability and accuracy And the effect of high sensitivity and quality control

Active Publication Date: 2015-09-23
CHENGDU UNIV
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Problems solved by technology

[0006] Related substances of fudosteine ​​may include raw materials, intermediates, by-products, degradation products, etc. These impurities may affect the effect of the drug and cause side effects. Some impurities themselves are toxic and should be strictly limited
The peak time of the existing inspection methods for related substances is about relatively early, it is difficult to completely separate the impurities that may exist in the sample, the repeatability of the measurement results is poor, and because the mobile phase is basically an aqueous phase, the damage to the filler is considerable, and the chromatographic Severe column loss

Method used

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  • Method for measuring fudosteine related substance by using amino column
  • Method for measuring fudosteine related substance by using amino column
  • Method for measuring fudosteine related substance by using amino column

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Embodiment 1

[0022] 1. Optimization of chromatographic conditions:

[0023] We compared (1) the selection of acetonitrile ratio by experiment: use 0.05mol / L KH 2 PO 4 -Acetonitrile (50:50), (40:60), (35:65), other conditions remain unchanged, the test is carried out, the result shows that the retention time of the concentration of acetonitrile of 65% is moderate, the degree of separation of impurities is good, and the proportion of acetonitrile of 65% is selected for use; (2) Selection of buffer salt concentration: other conditions remain unchanged for KH 2 PO 4 The concentration of the salt is selected, and a total of 5 salt concentrations of 0.1mol / L, 0.05mol / L, 0.02mol / L, 0.01mol / L, and 0.005mol / L are screened, and the result is that the buffer salt concentration has an impact on the peak shape. The higher the salt concentration, the sharper the peak, when the buffer salt concentration is 0.1mol / L KH 2 PO 4 When the baseline is uneven and the pressure fluctuates greatly, the salt c...

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Abstract

The invention discloses a method for measuring a fudosteine related substance by using an amino column and belongs to the technical field of pharmaceutical analysis. A chromatographic column (25cm*4.6mm, 5 microns) taking amino bonded silica gel bonded silica gel as a filler serves as the chromatographic column used in the method, 0.05mol / L of potassium dihydrogen phosphate solution (the pH of phosphoric acid is adjusted to 4.5) and acetonitrile in the ratio of 35:65 serve as mobile phase, the detection wavelength is 210nm, the flow rate is 1.0mL / min, a high performance liquid chromatography condition is the column temperature of 30 DEG C, and the fudosteine related substance is measured. According to the related substance measuring method provided by the invention, more impurities can be measured, separation degree between a main peak and impurities is better, trace impurities in a sample can be more scientifically and accurately measured, the using safety and the efficiency of the sample are improved, and the method has advanced nature.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for determining related substances of fudosteine ​​by using an amino column. Background technique [0002] Fudosteine ​​is a new type of expectorant, chemical name: (-)-(R)-2-amino-3-(3-hydroxypropylthio)-propionic acid. Chemical Structure: [0003] [0004] It is a compound with a basic skeleton of steine ​​developed by SSP Pharmaceutical Co., Ltd. in 1988 and has an expectorant effect. It can inhibit the proliferation of ring cells and regulate the normal state of mucus and mucosa in the respiratory tract. For bronchial asthma, chronic bronchitis, bronchiectasis, tuberculosis, pneumoconiosis, emphysema, atypical acid-fast bacillus infection, diffuse bronchitis and other chronic respiratory diseases. [0005] Both the national standard and the Japanese Pharmacopoeia of this variety use a conventional C18 column to determine its related substances, and there ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 唐克慧王宇驰张春然邓思思张静霞徐明琴李喆宇李成龙
Owner CHENGDU UNIV
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