Method for detecting (R)-etiracetam from medicine

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...

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 water content, 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

Images