Please use this identifier to cite or link to this item: http://hdl.handle.net/10603/129214
Title: Development and validation of chiral separation of some enantiomeric drugs by HPLC and LC MS
Researcher: K R Senthil Kumar
Guide(s): Meyyanathan S N
Keywords: Stability-indicating method, Validation, Chiral, Mebeverine
University: JSS University
Completed Date: 28/12/2015
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
Pagination: I-XII, 1-150p
URI: http://hdl.handle.net/10603/129214
Appears in Departments:College of Pharmacy

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02_certificates.pdf96.02 kBAdobe PDFView/Open
03_acknowledgement.pdf45.51 kBAdobe PDFView/Open
04_contents.pdf44.54 kBAdobe PDFView/Open
05_tablesfigures.pdf118.94 kBAdobe PDFView/Open
06_chapter 1.pdf455.54 kBAdobe PDFView/Open
07_chapter 2.pdf62.52 kBAdobe PDFView/Open
08_chapter 3.pdf133.66 kBAdobe PDFView/Open
09_chapter 4.pdf329.75 kBAdobe PDFView/Open
10_chapter 5.pdf1.53 MBAdobe PDFView/Open
11_chapter 6.pdf165.3 kBAdobe PDFView/Open
12_chapter 7.pdf982.42 kBAdobe PDFView/Open


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