Simultaneous Quantification of Famotidine and Ibuprofen in Pharmaceutical Dosage by Using Validated Stability Indicating LC Method

Abstract

A reverse phase liquid chromatographic analytical method was developed for the simultaneous determination of Famotidine and Ibuprofen content in tablet dosage form. The chromatographic separation was achieved by using YMC Cyano column with mobile phase containing a gradient mixture of 0.05M ammonium acetate in water as mobile phase A and acetonitrile as mobile phase B at a flow rate of 1.0 ml/min. Both of the analyte were quantified with a UV detector at 270 nm. Famotidine and ibuprofen tablet were subjected to the stress conditions of oxidation, acid hydrolysis, base hydrolysis and thermolysis and photolysis. The tablet was found to be stable under thermal and photolytic conditions but degradation was observed in base hydrolysis, acid hydrolysis and oxidation. The stability-indicating capability of this method was demonstrated by adequate separation of the degradation peaks from those of the actives in the stress degraded samples. The method was validated for linearity, specificity, system suitability, precision and accuracy in accordance with ICH guidelines. The proposed method was applied to quantify famotidine and ibuprofen in the combined pharmaceutical tablet and stability studies of the same.