Robust Stability Indicating HPLC Method Development for Drugs In Compounded Preparations
Document Type
Poster Presentation
Publication Date
4-17-2026
Keywords
fsc2026
Abstract
This study was done to develop a suitable stability indicating HPLC method to determine the degradation of naloxone in compounded preparations. This method will be used in future studies to investigate the beyond use date of compounded preparation which uses this active drug. Method was developed based on the USP monograph of naloxone. Once a suitable method was evaluated based on the system suitability parameters (like retention (RT), tailing factor, %CV),calibration curves were developed and the curve was validated by injecting random concentrations that were not considered for the plotting the calibration curve. Drug standards were then subjected to various stressors such as acidic, basic, oxidative stress; at ambient and heated conditions to measure the ability to detect the forced degradation. Data shows robust independent HPLC methods for naloxone through gradient, reverse phase chromatography for investigating the stability of compounded preparations.
Publication Information
Pietro, Jack; Owczarzak, Collin; McLean, Annelise; Alzien, Tala; Orock, Valentine; Woytowicz, Sara; Schneider, Christopher; Falcon, Christopher; and Rochani, Ankit, "Robust Stability Indicating HPLC Method Development for Drugs In Compounded Preparations" (2026). Fisher Showcase 2026. Paper 57.
https://fisherpub.sjf.edu/fsc2026/57
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Comments
Poster presented at the 2026 Fisher Showcase, St. John Fisher University, April 17, 2026.