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Development and validation of assay and impurities methods for acetaminophen and diphenhydramine tablets
Author(s) -
Kirkpatrick Douglas,
Momot Magdalene,
Anthony Clydewyn
Publication year - 2020
Publication title -
separation science plus
Language(s) - English
Resource type - Journals
ISSN - 2573-1815
DOI - 10.1002/sscp.202000006
Subject(s) - acetaminophen , diphenhydramine , chromatography , impurity , compendium , limiting , chemistry , detection limit , diphenhydramine hydrochloride , pharmacology , medicine , engineering , organic chemistry , mechanical engineering , archaeology , histamine , history , biochemistry
The United States Pharmacopeia compendium does not currently contain a documentary standard for acetaminophen and diphenhydramine hydrochloride tablets to determine quality. To address this gap, high‐performance liquid chromatography methods for assay and impurities were developed and validated. Marketed products contain different amounts of drug substances per unit (325–500 mg of acetaminophen and 12.5–25 mg of diphenhydramine), so two methods specific to each substance were required. Methods were designed for high throughput by limiting analysis time, and complexity was reduced by utilizing similar materials and instrumental configurations across methods. For each method, specificity, linearity, accuracy, and precision were demonstrated for the assay and impurity determination. Both methods were shown to be fit‐for‐purpose and may be considered for adoption as United States Pharmacopeia compendial standards.