Abstract
A simple, rapid, and accurate HPLC method was developed using high‐low chromatography (H‐LC), to determine the level of propyl gallate (PG) in an active pharmaceutical ingredient (API). The method utilizes a Waters Symmetry C‐8 column and a variable wavelength UV detector. The method employs isocratic conditions. The mobile phase consists of water and acetonitrile with phosphoric acid. The method is effective in determining the amount of PG in an API. The method was applied to process developmental samples to determine the effectiveness of PG loading and to monitor the levels of PG during the long term and accelerated stability studies. Spiking experiments of PG in the API demonstrated quantitative recovery. Ruggedness was determined as a function of solution stability. Sample solutions stored under ambient conditions are stable for an overnight period in methanol:acetic acid 99:1 v/v. The limit of detection (LOD) was determined to be 0.0006% w/w. The limit of quantitation (LOQ) was determined to be 0.002% w/w. The LOD and LOQ are based on a 10 mg/mL API sample solution.
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