Labetalol suspension was subjected to different harsh conditions to force and accelerate the degradation process to determine the degradation products over time. HPLC analytical method was developed and validated for the analysis. Mobile and stationary phase conditions were determined. Calibration curve was prepared to quantify labetalol concentration present in the drug product. Labetalol suspension would be analyzed for chemical stability from day zero to day 60 to establish its beyond-date-use. The stability-indicating assay for the compounded labetalol suspensions was validated based on the USP technical proposal for compounded preparation monograph development
Learning Objectives:
Develop and validate HPLC assay method and be able to analyze an oil based sample using HPLC.
