Development and Validation of a RP-HPLC Method for Determination of Related Substances and Degradants in Entacapone.

A new reverse phase-liquid chromatography (RP-HPLC) method has been developed for simultaneous determination of entacapone and its pharmacopoeia impurities, in-house impurities and degradation impurities (total 17 analytes). Chromatographic separation was achieved on a C18 column (size: 250 × 4.6 mm; 5 µm particle size) at a flow rate of 1.