Rapid densitometric method for simultaneous analysis of famotidine and domperidone in commercial formulations using HPTLC

摘要

A rapid and simple high performance thin layer chromatography (HPTLC) method was developed for simultaneous determination of famotidine and domperidone from combined dosage form and validated as per ICH guidelines. Separation was performed on silica gel precoated aluminum plate 60 F254, [(20 × 10 cm) as stationary phase and using a mobile phase comprising of ethyl acetate: methanol: water (8.0: 1.5: 0.3 v/v/v). After development, plates were observed under UV light at 288 nm. The Rf values found to be 0.42±0.02 and 0.67±0.02 for famotidine and domperidone respectively. Validation parameters of the proposed HPTLC method were in compliance with the ICH guidelines. The LOD and LOQ were found to 200 ng/spot and 300 ng/spot for famotidine and 100 ng/spot and 150 ng/spot for domperidone respectively. The percentage average recovery was found to be 98.88 % and 98.26 % for famotidine and domperidone respectively. Famotidine and domperidone were quantified and found to be 97.11±0.27 % and 97.78±0.35 % in combined dosage form respectively. The described method has the advantage of being rapid and easy. Hence it can be applied for routine quality control analysis of Famotidine and domperidone from combined dosage forms.