Development and Validation of a Stability-Indicating RP-UPLC Method for the Quantitative Analysis of antiparkinson drug and its related impurities

High efficiency, cost effectiveness and short run time are the basic requirements of high-speed chromatographic separations. To fulfill these requirements, an advanced separation technique, ultraperformance liquid chromatography (UPLC), has shown promising developments. A rapid, specific, sensitive, and precise reverse-phase UPLC method was developed for the determination of antiparkinson drug and its impurities. In this work, a new gradient reverse phase chromatographic method using UPLC for the determination was done for active pharmaceutical ingredient in the presence of degradation products, and its process related impurities.The chromatographic separation was achieved on a Waters Acquity BEH C18 column (50 mm, i.d., 2.1 mm, 1.7 μm) within a short runtime of 4 minutes using a mobile phase of 5 mM potassium phosphate and acetonitrile, at a flow rate of 0.5 mL/min at an ambient temperature. Forced degradation studies were also performed for antiparkinson bulk drug samples to demonstrate the stabilityindicating power of the UPLC method. Linearity range was LOQ-200% with respect to 100 μg mL of active pharmaceutical ingredient for related impurities; Linearity range was 40-160% with respect to 10 μg mLof active pharmaceutical ingredient for assay calculated by 5 determinations. Comparison of system performance with conventional high-performance liquid chromatography was made with respect to analysis time, efficiency, and sensitivity. The method is validated according to the ICH guidelines and is applied successfully for the quantitative determination of antiparkinson drug and its related impurities.