Separation and detection method of optical isomer impurities in Pinefibrate
By using a cellulose-tris(3,5-dimethylphenylcarbamate)-coated silica gel column and a trifluoroacetic acid aqueous solution-acetonitrile mixed solution, the problem of detecting S-type optical isomer impurities in Pemabet was solved, and efficient separation and accurate quantification were achieved, ensuring the quality of the drug.
CN120609933APending Publication Date: 2025-09-09南京联智医药科技有限公司
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Patent Information
- Application Number
- CN202510818033.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-06-18
- Publication Date
- 2025-09-09
AI Technical Summary
Technical Problem
The existing technology lacks effective methods to detect and separate S-type optical isomer impurities in Pemabet, which affects drug quality control and patient medication safety.
Method used
The optical isomer impurities in Pemabet were detected by high performance liquid chromatography using a chromatographic column filled with silica gel coated with cellulose-tris(3,5-dimethylphenylcarbamate) and a mixed solution of trifluoroacetic acid aqueous solution and acetonitrile as the mobile phase.
Benefits of technology
The efficient separation and accurate quantification of optical isomers in Pemabet were achieved, ensuring the reliability and safety of drug quality.
✦ Generated by Eureka AI based on patent content.
Abstract
The invention discloses a method for separating and detecting optical isomer impurities in Pinefibrate, and belongs to the technical field of pharmaceutical analysis. According to the method, a chromatographic column with silica gel coated with cellulose-tri (3, 5-dimethyl phenyl carbamate) on the surface as a filling agent is adopted, a mixed solution of a trifluoroacetic acid aqueous solution and acetonitrile is used as a mobile phase for elution, and the optical isomer impurities in a Pengfibrate sample are detected by high performance liquid chromatography. The optical isomer impurity is (2S)-2-[3-({1, 3-benzoxazole-2-yl [3-(4-methoxyphenoxy) propyl] amino} methyl) phenoxy] butyric acid. According to the method disclosed by the invention, efficient separation of optical isomers which are mirror images of each other is realized by utilizing a chiral stationary phase, the specificity is high, the separation degree is good, and R-configuration optical isomer impurities and S-configuration optical isomer impurities of Pengfibrate can be well separated; the method has the advantages of high sensitivity and good repeatability, and can accurately quantify the content of trace S-configuration optical isomer impurities in Pinefibrate.
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