Validated HPTLC method for simultaneous quantitation of famotidine and domperidone in bulk drug and formulation.

Abstract

This paper describes a new, simple, precise, and accurate HPTLC method for simultaneous quantitation of famotidine (FAM) and domperidone (DOM) as the bulk drug and in tablet dosage forms. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of n-butanol: water 6: 1(v/v). Densitometric evaluation of the separated zones was performed at 280 nm. The two drugs were satisfactorily resolved with RF values 0.27±0.01 and 0.58±0.01 for FAM and DOM, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (200-1200 ng.spot-1 for FAM and 100-600 ng.spot-1 for DOM), precision (intra-day RSD 0.05–0.40 % and inter-day RSD 0.13–0.39 % for FAM, and intra-day RSD 0.10–0.20 % and inter-day RSD 0.13–0.60 % for DOM), accuracy (99.10±0.116 % for FAM and 98.57±1.078 % for DOM), and specificity, in accordance with ICH guidelines. Keywords: Thin Layer Chromatography; Densitometry; Validation; Quantification; Famotidine; Domperidone;