Abstract

SALEEM, Atif et al. Simultaneous Determination of Acetaminophen, Pamabrom and Pyrilamine Maleate in Pharmaceutical Formulations Using Stability Indicating HPLC Assay Method. J. Mex. Chem. Soc [online]. 2015, vol.59, n.2, pp.93-98. ISSN 1870-249X.

A simple, specific and accurate stability indicating RP-HPLC method was developed for the determination of acetaminophen, pamabrom and pyrilamine maleate simultaneously in pharmaceutical dosage forms. Successful separation of all the components was enacted within 10 min using C18 column with mobile phase of methanol and acidified water (pH 1.8) in the ratio of (27: 73 v/v respectively). Flow rate of the mobile phase was 1.5 mL/min with detection at 300 nm. The method was validated in accordance with ICH guidelines. Response was a linear function of concentration over the range of 50- 150 μg/mL for acetaminophen, 2.5-7.5 μg/mL for pamabrom and 1.5-4.5 μg/mL for pyrilamine maleate. The method resulted in excellent separation of all the analytes along with their stress induced degradation products with acceptable peak tailing and good resolution. It is therefore can be applied successfully for simultaneous determination of acetaminophen, pamabrom and pyrilamine maleate in pharmaceutical formulations and their stability studies.

Keywords : RP-HPLC; Acetaminophen; Pamabrom; Pyrilamine; ICH guidelines.

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