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Method for determination of impurity A in Cetilistat in biological sample

A technology of biological samples and new listat, which is applied in the field of medicine to achieve the effect of improving analysis speed, ensuring accuracy and high precision

Active Publication Date: 2019-02-01
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the complexity and variety of sources and types of process impurities in new lisstat APIs, the control of process impurities in such APIs has always been a challenging task

Method used

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  • Method for determination of impurity A in Cetilistat in biological sample
  • Method for determination of impurity A in Cetilistat in biological sample
  • Method for determination of impurity A in Cetilistat in biological sample

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] The methodological investigation of embodiment 1 detection method of the present invention

[0024] 1. Preparation of standard solution

[0025] (1) Preparation of standard series solutions

[0026] The preparation method of the standard stock solution of the new lixistat impurity A: accurately weigh an appropriate amount of the new lixistat impurity A standard, put it in a 10mL volumetric flask, add tetrahydrofuran to dissolve it to a constant volume, and make a new lixistat with a concentration of 1000mg / L Impurity A standard stock solution.

[0027] Dilute the standard stock solution of the new lixistat impurity A with 20% tetrahydrofuran acetonitrile according to a certain ratio to prepare standard working solutions with concentration gradients of 100, 50.0, 20.0, 4.00, 1.00, 0.400 and 0.200 mg / L.

[0028] (2) Preparation of internal standard solution

[0029] Preparation method of internal standard orlistat standard stock solution: Accurately weigh an appropriat...

Embodiment 2

[0059] Embodiment 2 new lixistat impurity A suspension rat pharmacokinetic test

[0060] Take 12 SD rats with a body weight of about 300g and divide them into 3 groups, half male and half male; respectively intragastric administration of the new lisstat impurity A suspension, low, medium and high dose groups were 20mg / kg, 80mg / kg, respectively. kg, 320mg / kg. On the day of administration, the body weight was weighed, and the dosage and corresponding volume were accurately calculated according to the body weight. Rats in each group took blank blood from the subclavian vein before administration, and 0.2 mL of blood at 0.5h, 0.25, 0.5, 1, 3, 6, 9, 12 and 24h after administration, centrifuged the blood at 4000rpm for 10min, and took the upper layer Plasma was clarified and immediately stored in a -20°C refrigerator for determination.

[0061] A high-throughput method of ultra-high performance liquid chromatography-tandem mass spectrometry (LC-MS / MS) was used to determine the new...

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Abstract

The invention relates to a method for determination of an impurity A in Cetilistat in a biological sample, and belongs to the technical field of medicines. The method adopts ultra-high performance liquid chromatography-electrospray ionization tandem mass spectrometry (UPLC-MS / MS) to detect the concentration of the Cetilistat impurity A in the biological sample. The established LC-MS / MS determination method for a Cetilistat impurity A plasma sample meets the analyzing requirement of 2015 edition of Chinese pharmacopoeia and (chemical drug non-clinical pharmacokinetics research technique governing principle) issued by SFDA in 2014 for the biological sample in the aspects of accuracy, precision, specialization, stability, the extraction recovery rate, the matrix effect and the like; and a powerful guarantee is provided for development of new drugs of Cetilistat and guidance of clinical rational drug use.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a method for measuring a biological sample of impurity A in new lixistat. Background technique [0002] Neolistat is developed by Shandong New Times Pharmaceutical Co., Ltd. It is mainly a drug for the treatment of obesity and its complications. It can inactivate the enzyme by forming a covalent bond with the active serine site of gastrointestinal lipase and pancreatic lipase , to reduce calorie intake and control weight. The advantage is that it does not act on the nervous system, does not affect the activity of other enzymes in the gastrointestinal tract, is not absorbed into the blood, does not suppress appetite, and does not require dietary restrictions. It is a new and powerful inhibitor of specific gastrointestinal lipase. Due to the complexity and variety of sources and types of process impurities in new lisstat APIs, the control of process impurities in such...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N33/50
CPCG01N30/02G01N30/06G01N33/5008
Inventor 张贵民王现珍吕圆圆
Owner LUNAN PHARMA GROUP CORPORATION
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