Development and validation of chiral separation of some enantiomeric drugs by HPLC and LC MS

Abstract

quotThis study deals with the development and validation of chiral separation of some enantiomeric drugs by HPLC and LC-MS methods. Three racemic drugs namely Mebeverine hydrochloride, Orphenadrine citrate and Meclizine hydrochloride for which there were no HPLC and LC-MS methods reported for the estimation of enantiomers in pharmaceutical formulations and their stability in different stress newlineconditions were selected for the present study The chromatographic conditions like detection wavelength/mass range, nature and composition of mobile phase, nature of stationary phase, peak modifiers, flow rate etc. were optimised for the best possible separation and quantification of the analytes. newline newlineForced degradation studies on the selected racemic drugs using acid, alkaline, neutral, oxidative, photolytic UV degradations were performed. The developed HPLC and LC-MS methods were validated for their transferability to other laboratories, in terms of specificity, selectivity, accuracy, precision, linearity and range, detection and quantification limits, ruggedness and robustness and system suitability. The validation studies carried out revealed that the developed methods satisfy the ideal characteristics of the analytical methods. newline newlineThe direct chiral HPLC and LC-MS methods developed in the present study for the estimation were found to be simple, rapid, accurate, precise, specific, linear and rugged. They are thus suitable for the estimation of enantiomers in raw materials and formulations. newlinequot newline