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A kind of analytical method for determination of lubiprostone test substance related substances

A lubiprostone and analysis method technology, applied in the field of drug analysis, can solve problems such as the instability of lubiprostone structure, and achieve the effect of ensuring controllability

Active Publication Date: 2022-07-05
NANJING CHIA TAI TIANQING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the structure of lubiprostone itself is unstable, and there will be tautomerism between compound L and compound L':

Method used

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  • A kind of analytical method for determination of lubiprostone test substance related substances
  • A kind of analytical method for determination of lubiprostone test substance related substances
  • A kind of analytical method for determination of lubiprostone test substance related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0080] Embodiment 1 Determination method of related substances

[0081] Take an appropriate amount of lubiprostone test product, accurately weigh it, dissolve and dilute it with acetonitrile to make a solution containing about 5 mg per 1ml, as the test solution; take an appropriate amount of lubiprostone reference substance, accurately weigh it, and use Acetonitrile is dissolved and diluted to make a solution containing about 10 μg per 1ml, as a reference solution; another appropriate amount of lubiprostone, compound of formula I, compound of formula II, compound of formula III, compound of formula IV, compound of formula V reference substance is taken. , accurately weighed, dissolved in acetonitrile and diluted respectively to make a solution containing about 5 mg of lubiprostone per 1 ml, a solution containing about 5 μg of the compound of formula I per 1 ml, and a solution of about 5 μg of the compound of formula II per 1 ml, Each 1 ml of a solution containing about 5 μg of...

Embodiment 2

[0090] Embodiment 2 Reproducibility experiment of determination of related substances

[0091] Take an appropriate amount of the test sample, add acetonitrile to dissolve and dilute to make a solution containing about 5mg per 1ml, as the test sample solution, prepare six copies in parallel, according to the method described in Example 1, sample injection analysis, and calculate with the self-control method Each impurity and total impurity content were investigated to investigate the repeatability of this method. The measurement results are shown in the table below:

[0092] Repeat test results table

[0093] sample 1 2 3 4 5 6 Compound of formula III (%) 0.04 0.04 0.04 0.04 0.04 0.05 Compound of formula I (%) not detected not detected not detected not detected not detected not detected Compound of formula IV (%) not detected not detected not detected not detected not detected not detected Compound of formula II (...

Embodiment 3

[0095] Example 3 Intermediate Precision Experiment of Related Substances

[0096] According to the method described in Example 1, two analysts respectively measured each impurity and total impurity content on two different high-performance liquid chromatographs according to the method for determination of related substances. The intermediate precision results of the method for the determination of the substances are shown in the following table:

[0097] Table of intermediate precision results for related substances

[0098]

[0099] As can be seen from the above table, the results of the intermediate precision show that the content of the compound of formula III is 0.03% to 0.05%, the maximum single impurity content is: 0.03% to 0.04%, and the total impurity content fluctuates between 0.07% and 0.10%. The method has good intermediate precision.

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Abstract

The present invention provides an analytical method for the determination of lubiprostone test substance related substances. The method adopts reversed-phase high performance liquid chromatography to separate and determine the lubiprostone compound, the compound of formula I, the compound of formula II and the compound of formula III. Compounds, Compounds of Formula IV and Compounds of Formula V. The solvent of this method does not interfere with the detection of impurities, the specificity of the method is good, and the detection method is simple, high in sensitivity, good in repeatability and good in accuracy. Controllability of ketone quality.

Description

technical field [0001] The invention belongs to the field of drug analysis, and particularly relates to a high-performance liquid chromatography analysis method for lubiprostone related substances. [0002] technical background [0003] Lubiprostone (Compound L) It is a localized chloride channel activator, which can selectively activate type 2 chloride channels located on the luminal cell membrane of the tip of the gastrointestinal tract, increasing the secretion of intestinal fluid and the motility of the intestine, thereby increasing defecation. Lubiprostone is approved for the treatment of chronic idiopathic constipation in adults, constipation-predominant irritable bowel syndrome in adult women, and opioid-induced constipation. However, the structure of lubiprostone itself is unstable, and there will be tautomerism of compound L and compound L': [0004] [0005] In the quality control of the test product of lubiprostone, in the existing literature, such as the pat...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 王丽娟胡越吴晶王华萍兰公剑柴雨柱徐丹朱春霞田舟山
Owner NANJING CHIA TAI TIANQING PHARMA
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