Validation of an HPLC method for the determination of CP-93,393 in CP-93,393-1 tablets.
A reversed-phase high performance liquid chromatographic (HPLC) assay developed for the CP-93,393-1 drug substance was adapted for use with CP-93,393-1 tablets. Using a novel experimental matrix, validation was performed to obtain linearity, reproducibility and recovery and to meet current regulatory requirements. Deviations in the sample preparation procedure were performed to demonstrate the ruggedness of the assay.
Dumont
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Pfizer Central Research, Analytical Research and Development, Groton, CT 06340, USA.
Colgan
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ST
Reed
R H
RH
Haggan
G R
GR
D014151:Anti-Anxiety Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D005079:Excipients; D011719:Pyrazines / Q000032:analysis*; D015203:Reproducibility of Results; D012371:Robotics; D013388:Succinimides / Q000032:analysis*; D013607:Tablets
D014151:Anti-Anxiety Agents; C109842:CP 93393; D005079:Excipients; D011719:Pyrazines; D013388:Succinimides; D013607:Tablets