Evaluation of Chiral Liquid Chromatographic Method for Separation and Quantification of Isomers of Brivaracetam. 2022

Thirupathi Choppari, and Srinivasu Gunnam, and Lakshmi Narayana Chennuru, and Parameswara Murthy Cherla, and M V N Kumar Talluri
Analytical & Separation Services, Daicel Chiral Technologies (India) Pvt Ltd, Survey No. 542/2, IKP Knowledge Park, Turkapally, Shamirpet Mandal, Medchal-Malkajgiri District, Hyderabad-500101, Telangana, India.

A selective, sensitive and robust chiral analytical method was developed for the quantification of Brivaracetam (BRV) and its three isomers. Systematic chiral chromatographic elution process was executed in different modes on chiral columns of polysaccharide based to attain the finest condition. The analytical method was developed by utilizing immobilized polysaccharide chiral column (CHIRALPAK IG-U) with reversed phase under isocratic condition containing acetonitrile and 10 mM ammonium bicarbonate in the proportion of 40:60 (v/v). The mobile phase flow rate and column temperature were monitored at 0.3 mLmin-1 and 25°C with a resolution of more than 2.0. The eluted components from the column were processed at 212 nm UV detection. The limit of detection and limit of quantification values of BRV, 2R, 4S-Isomer, 2R, 4R-Isomer and 2S, 4S-Isomers were found to be 0.0066/0.02, 0.0035/0.0107, 0.0036/0.0109 and 0.005/0.0152 µgml-1 respectively. Precision, linearity, accuracy and robustness were conducted according to ICH guidelines and the findings were within the acceptable limits. The proposed analytical method was found to be precise, accurate and specific for the quantification of enantiomer and its diastereomers for drug product and drug substance of BRV.

UI MeSH Term Description Entries
D007536 Isomerism The phenomenon whereby certain chemical compounds have structures that are different although the compounds possess the same elemental composition. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 5th ed) Isomerisms
D011760 Pyrrolidinones A group of compounds that are derivatives of oxo-pyrrolidines. A member of this group is 2-oxo pyrrolidine, which is an intermediate in the manufacture of polyvinylpyrrolidone. (From Merck Index, 11th ed) Pyrrolidinone,Pyrrolidone,Pyrrolidones
D002851 Chromatography, High Pressure Liquid Liquid chromatographic techniques which feature high inlet pressures, high sensitivity, and high speed. Chromatography, High Performance Liquid,Chromatography, High Speed Liquid,Chromatography, Liquid, High Pressure,HPLC,High Performance Liquid Chromatography,High-Performance Liquid Chromatography,UPLC,Ultra Performance Liquid Chromatography,Chromatography, High-Performance Liquid,High-Performance Liquid Chromatographies,Liquid Chromatography, High-Performance
D002853 Chromatography, Liquid Chromatographic techniques in which the mobile phase is a liquid. Liquid Chromatography
D013237 Stereoisomerism The phenomenon whereby compounds whose molecules have the same number and kind of atoms and the same atomic arrangement, but differ in their spatial relationships. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 5th ed) Molecular Stereochemistry,Stereoisomers,Stereochemistry, Molecular,Stereoisomer

Related Publications

Thirupathi Choppari, and Srinivasu Gunnam, and Lakshmi Narayana Chennuru, and Parameswara Murthy Cherla, and M V N Kumar Talluri
November 2000, Journal of chromatography. A,
Thirupathi Choppari, and Srinivasu Gunnam, and Lakshmi Narayana Chennuru, and Parameswara Murthy Cherla, and M V N Kumar Talluri
June 2006, Journal of pharmaceutical and biomedical analysis,
Thirupathi Choppari, and Srinivasu Gunnam, and Lakshmi Narayana Chennuru, and Parameswara Murthy Cherla, and M V N Kumar Talluri
January 1986, Methods in enzymology,
Thirupathi Choppari, and Srinivasu Gunnam, and Lakshmi Narayana Chennuru, and Parameswara Murthy Cherla, and M V N Kumar Talluri
January 1988, Journal of pharmaceutical and biomedical analysis,
Thirupathi Choppari, and Srinivasu Gunnam, and Lakshmi Narayana Chennuru, and Parameswara Murthy Cherla, and M V N Kumar Talluri
March 1976, Journal of chromatography,
Thirupathi Choppari, and Srinivasu Gunnam, and Lakshmi Narayana Chennuru, and Parameswara Murthy Cherla, and M V N Kumar Talluri
April 2022, Chemical record (New York, N.Y.),
Thirupathi Choppari, and Srinivasu Gunnam, and Lakshmi Narayana Chennuru, and Parameswara Murthy Cherla, and M V N Kumar Talluri
April 2002, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences,
Thirupathi Choppari, and Srinivasu Gunnam, and Lakshmi Narayana Chennuru, and Parameswara Murthy Cherla, and M V N Kumar Talluri
September 2017, Journal of chromatography. A,
Thirupathi Choppari, and Srinivasu Gunnam, and Lakshmi Narayana Chennuru, and Parameswara Murthy Cherla, and M V N Kumar Talluri
January 1980, Analytical biochemistry,
Thirupathi Choppari, and Srinivasu Gunnam, and Lakshmi Narayana Chennuru, and Parameswara Murthy Cherla, and M V N Kumar Talluri
November 2017, Journal of chromatographic science,
Copied contents to your clipboard!