Development and Validation of Chiral Separation of some enantiomeric drugs by HPLC and LCMS

Abstract

This thesis deals with the studies carried out by the writer in the laboratory for the past four years on the development and validation of chiral separation of some enantiomeric drugs by HPLC and LC-MS methods. Thesis begins with a brief introduction of the reasons for analyzing enantiomeric drugs and introduction to the analytical methods used like HPLC and LC-MS. The methods used for the quantitative analysis of enantiomers and the introduction to the chiral separation are given. newlineThesis deals with the aim and objective of the present work, the reasons for analysing the enantiomers and need for newer analytical methods for the estimation of enantiomers in pharmaceutical formulation are briefly discussed. Thesis deals with the reviews of literature on the analytical methods available for the estimation of the drug candidates in pharmaceutical formulations are explained. Thesis deals with the materials and instruments used in the experimental procedures adopted. It describes in detail the procedure adopted for the optimisation of the chromatographic conditions for the chiral separation of drugs by HPLC and LC-MS methods and for the estimation of enantiomers in the selected drug candidates are presented and discussed. Forced degradation studies on the selected racemic drugs using acid, alkaline, neutral, oxidative and photolytic degradations and quantification of enantiomers by HPLC in different stress conditions are presented and discussed. The results obtained are presented and discussed. HPLC and LC-MS chromatograms of the standard and sample solutions, calibration curves for the selected analytes are also presented. The results of the experiments carried out to check the accuracy, reproducibility of the methods carried out are presented and discussed in detail. System suitability studies and forced degradation studies carried out for various methods developed are also presented and discussed. newline newline