Method for detecting (R)-etiracetam from medicine

A detection method and detection condition technology, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of chromatographic column drop, trouble, and reduce the quality control standard limit of levetiracetam raw materials, so as to achieve no tailing, Improve the quality of medicines and detect the peak shape of the spectrum

Active Publication Date: 2019-05-17
CHENGDU BRILLIANT PHARMA CO LTD
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  • Abstract
  • Description
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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 pretrea

Method used

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  • Method for detecting (R)-etiracetam from medicine
  • Method for detecting (R)-etiracetam from medicine
  • Method for detecting (R)-etiracetam from medicine

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Embodiment 2

[0065] Example 2 Analytical method validation

[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 4:

[0068] Table 4 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 (R)-etiracetam (R-isomer) from levetiracetam injection. Qualitative and/or quantitative detection is carried out on the R-isomer through adoption of a high performance liquid chromatography. Liquid chromatography detection conditions comprise the fact that a chromatographic column is a cellulose-tris(3, 5-dichlorophenyl carbamate) silica gel column; and a mobile phase comprises n-hexane and anhydrous ethanol, wherein n-hexane (vol.%): anhydrous ethanol (vol.%) is equal to 90-70: 10-30, and isocratic elution is employed for the mobile phase. Through adoption of the method provided by the invention, the (R)-etiracetam in the levetiracetam injection can be effectively detected, and the method has specificity and stability indication capacity. Thelevetiracetam injection can be directly detected after being diluted. A sample does not need to be preprocessed. The method is convenient and rapid. According to the method provided by the invention,limit of detection reaches 0.003%, limit of quantitation reaches 0.005%, and the method 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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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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