Volume 60, Numbers 7-8, 455-460, DOI: 10.1365/s10337-004-0386-6

RP-HPLC Determination of Famotidine and its Potential Impurities in Pharmaceuticals

N. Helali, F. Darghouth and L. Monser

View Related Documents

Abstract

A simple, sensitive, and rapid reversed-phase high-performance liquid chromatographic method has been developed for determination of famotidine (FMT) and its impurities in pharmaceutical formulations. Separations were performed on a Supelcosil LC18 column with an isocratic mobile phase—13:87 (v/v) acetonitrile–0.1 M dihydrogen phosphate buffer containing 0.2% triethylamine (pH 3.0). The mobile phase flow rate was 1 mL min–1 and the detection wavelength was 265 nm. Response was linearly dependent on concentration between 1 and 80 mgrg mL–1 (regression coefficient, R2, from 0.9981 to 0.9999). RSD from determination of method repeatability (intraday) and reproducibility (interday) were <2% (n=6). Lowest detectable concentrations ranged from 0.08 to 0.14 mgrg mL–1. The proposed liquid chromatographic method can be satisfactorily used for routine quality control of famotidine in pharmaceutical formulations.

Keywords  Column liquid chromatography - Famotidine and related impurities - Pharmaceutical formulations

Fulltext Preview

Image of the first page of the fulltext document