Analysis of Acetaminophen, Phenylephrine Hydrochloride, Diphenhydramine Hydrochloride, and Ascorbic Acid in a Capsule Preparation

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.

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Analysis of Acetaminophen, Phenylephrine Hydrochloride, Diphenhydramine Hydrochloride, and Ascorbic Acid in a Capsule Preparation

Cited by 3 publications

References 7 publications

Determination of Acetaminophen in Pharmaceutical Preparations and Body Fluids by High-Performance Liquid Chromatography with Electrochemical Detection

Determination of Acetaminophen in Pharmaceutical Preparations and Body Fluids by High-Performance Liquid Chromatography with Electrochemical Detection

Spectrophotometric Determination of Diphenhydramine Hydrochloride using Dipicrylamine

Development and validation of assay and impurities methods for acetaminophen and diphenhydramine tablets

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