Validated Stability-Indicating HPLC and UPLC Assay Methods for the Determination of Entacapone in Pharmaceutical Dosage Forms

Abstract

In the present study, new isocratic stability-indicating reverse phase chromatographic methods were developed using HPLC and UPLC systems for the determination of entacapone (ENT) in its pharmaceutical dosage forms. Ultra performance liquid chromatography (UPLC) using small sub-2 μm particles and high-performance liquid chromatography (HPLC) were compared for separation and determination of the ENT using Acquity HSS C18 (50 × 2.1 mm, 1.8 µm) and Xbridge C18 (150 × 4.6 mm, 5.0 µm) columns by UPLC and HPLC, respectively. When using UPLC, the run time could be reduced five fold and actually the solvent consumption decreased 10 times. The proposed UPLC method would decrease the consumption of organic solvents and reagents. The present methods were validated according to ICH guideline. All analytical procedures including sample preparation, flow rate, run time of the analytical systems were at low levels. Forced degradation studies were also performed for both compounds in bulk drug samples to demonstrate the specificity and stability-indicating comparative advantage of both methods.