HPTLC method for simultaneous determination of amlodipine besylate and enalapril maleate in pharmaceutical formulation

Abstract

A rapid and simple high performance thin layer chromatography (HPTLC) method with densitometry at ?= 223 nm was developed and validated for simultaneous determination of Amlodipine and Enalapril from pharmaceutical preparation. Separation was performed on aluminum-backed silica gel 60F₂₅₄ HPTLC plates as stationary phase and using a mobile phase comprising of Toluene: Isopropanol: Glacial acetic acid (GAA): Methanol (6: 2: 0.6: 0.5 v/v/v/v) and 20 ml of mobile phase was used per chromatography run. After development, plates were observed under UV light. The validated lowest limit of detection was 80ng/spotand 200ng/spot whereas lowest limit of quantification was 150ng/spot and 400ng/spotfor Amlodipine and Enalapril respectively. The percentage assay of Amlodipine and Enalapril was found between 99.74 to 100.66% and 99.89 to 100.42% respectively. The described method has the advantage of being rapid and easy. Hence it can be applied for routine quality control analysis of Amlodipine and Enalapril from pharmaceutical preparation and stability studies.