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A method for detecting Devetiracetam from medicine

A detection method and technology of detection conditions, which can be applied to measurement devices, instruments, scientific instruments, etc., can solve problems such as trouble, drop of chromatographic column, lowering of the quality control standard limit of levetiracetam raw materials, etc., so as to achieve control of drug quality, Improve drug quality and peak shape

Active Publication Date: 2022-01-25
CHENGDU BRILLIANT PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the USP 40 raw material quality standard and the import registration standard of levetiracetam injection, the chromatographic columns used are all porous spherical silica gel columns coated with amylose tri-3,5 dimethylphenylcarbamate on the surface. This type of chromatographic column cannot be in contact with water. If it is used for the detection of levetiracetam injection, the column efficiency will drop rapidly, and the sample of levetiracetam injection can only be subjected to cumbersome pretreatment to remove the After removing the moisture, the method of detecting various substances in the raw material of levetiracetam is used for quality inspection, which is very troublesome
[0007] Therefore, even if the improved technology reduces the quality control standard limit of levetiracetam bulk drug and improves the quality control technology of levetiracetam bulk drug, it cannot fundamentally solve how to conveniently and accurately test levetiracetam Problems of Good Quality Control of Tan Injection

Method used

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  • A method for detecting Devetiracetam from medicine
  • A method for detecting Devetiracetam from medicine
  • A method for detecting Devetiracetam from medicine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Blank solution: absolute ethanol.

[0055] Blank auxiliary material stock solution: Prepare a blank solution without levetiracetam raw material according to the prescription; weigh about 4.5g of sodium chloride, about 0.82g of sodium acetate, and about 0.6ml to 500ml of 5% acetic acid in water for injection middle.

[0056] Blank excipient solution: Precisely measure 1.0ml of blank excipient stock solution into a 10ml measuring bottle, dilute with absolute ethanol to the mark, and obtain.

[0057] System suitability solution: Weigh 11.60mg of levetiracetam racemate reference substance, put it in a 100ml measuring bottle, dissolve it with absolute ethanol and dilute to the mark, and make a solution containing about 0.1mg per 1ml, to obtain .

[0058]Levetiracetam reference solution: Accurately weigh 11.03mg of levetiracetam reference substance, put it in a 200ml measuring bottle, dissolve it with absolute ethanol and dilute to the mark, and make a solution containing a...

Embodiment 2

[0065] Example 2 Analytical method verification

[0066] The invention preliminarily establishes the chromatographic conditions of the R-isomer analysis method, and the test results show that the above method can effectively separate the R-isomer from the main drug.

[0067] The specific verification results are shown in Table 2:

[0068] Table 2 Summary of validation of analytical methods for R-isomer of levetiracetam injection

[0069]

[0070]

[0071]

[0072] The results show that the system applicability and specificity, detection limit and quantification limit, linearity and range, precision, accuracy and durability of the method of the present invention's detection method all meet the requirements, proving that the detection method of the present invention is suitable for levothyrocytosis Detection of the R-isomer of Piracetam.

[0073] Further compare and illustrate technical effect of the present invention by control test below:

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Abstract

The invention discloses a method for detecting devetiracetam (R-isomer) from levetiracetam injection, and adopts high performance liquid chromatography to carry out qualitative or / and quantitative detection of the R-isomer, The detection condition of liquid chromatography comprises: chromatographic column: cellulose-three (3,5-dichlorophenyl carbamate) silica gel column; Mobile phase: n-hexane, dehydrated alcohol; Wherein, n-hexane (vol.% ): absolute ethanol (vol.%)=90~70: 10~30; the mobile phase adopts isocratic elution. The method of the invention can effectively detect the levetiracetam in the levetiracetam injection, and has specificity and stability indicating ability. Moreover, the levetiracetam injection can be directly diluted and tested without pretreatment of samples, which is convenient and fast; the detection limit of the method of the invention reaches 0.003%, and the quantification limit reaches 0.005%, which is accurate and sensitive.

Description

technical field [0001] The invention relates to the field of detecting impurities in medicines, in particular to a method for detecting devetiracetam in medicines. Background technique [0002] Levetiracetam, also known as Levetiracetam, Levetiracetam, Levetiracetam, is a white crystalline powder chemical. Chemical name (S)-α-ethyl-2-oxo-1-pyrrolidineacetamide, molecular formula is C 8 h 14 N 2 o 2 , the molecular weight is 170.20900. Levetiracetam is an antiepileptic drug, which is mainly used clinically for the additional treatment of partial seizures in adults and children over 4 years old with epilepsy. [0003] As we all know, the content of process impurities in the drug determines the quality of the drug, and levetiracetam is a chiral compound with a chiral center, and its R-isomer, devetiracetam, has no antiepileptic effect. Obviously, it can be seen that the content of devetiracetam will greatly affect the drug efficacy of levetiracetam-related drugs, and it i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 丁凤童庆国罗鸣黄浩喜苏忠海
Owner CHENGDU BRILLIANT PHARMA CO LTD
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