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    DEVELOPMENT OF HPLC METHODS FOR PHARMACEUTICALLY RELEVANT MOLECULES; METHOD TRANSFER TO UPLC: COMPARING METHODS STATISTICALLY FOR EQUIVALENCE

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    Genre
    Thesis/Dissertation
    Date
    2011
    Author
    Ganti, Satyakala
    Advisor
    Varnum, Susan A.
    Committee member
    Wunder, Stephanie L.
    Zdilla, Michael J., 1978-
    Borenstein, Michael R.
    Department
    Chemistry
    Subject
    Chemistry, Analytical
    Galantamine
    Hplc: High Pressure Liquid Chromatography
    Method Comparison
    Statistical Analysis
    Uhplc: Ultra High Pressure Liquid Chromatography
    Permanent link to this record
    http://hdl.handle.net/20.500.12613/1265
    
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    DOI
    http://dx.doi.org/10.34944/dspace/1247
    Abstract
    High Pressure Liquid Chromatography (HPLC) is a well-known and widely used analytical technique which is prevalent throughout the pharmaceutical industry as a research tool. Despite its prominence HPLC possesses some disadvantages, most notably slow analysis time and large consumption of organic solvents. Ultra Pressure Liquid Chromatography (UPLC) is a relatively new technique which offers the same separation capabilities of HPLC with the added benefits of reduced run time and lower solvent consumption. One of the key developments which facilitate the new UPLC technology is sub 2-µm particles used as column packing material. These particles allow for higher operating pressures and increased flow rates while still providing strong separation. Although UPLC technology has been available since early 2000, few laboratories have embraced the new technology as an alternative to HPLC. Besides the resistance to investing in new capital, another major roadblock is converting existing HPLC methodology to UPLC without disruption. This research provides a framework for converting existing HPLC methods to UPLC. An existing HPLC method for analysis of Galantamine hydrobromide was converted to UPLC and validated according to ICH guidelines. A series of statistical evaluations on the validation data were performed to prove the equivalency between the original HPLC and the new UPLC method. This research presents this novel statistical strategy which can be applied to any two methodologies to determine parity.
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