Waters HPLC e-2695 quaternary pump Photo diode array detector (PDA) detector of 2998 instrument was used to separate Opicapones associated contaminants utilizing a verified stability-indicating Reverse phase high performance liquid chromatography (RP-HPLC) procedure. The chromatographic separation of Opicapone with its associated impurities is obtained by utilizing gradient elution with a tampon containing 0.1% triethyl amine and acetonitrile as a mobile phase with a flow rate of 1 ml/minute at ambient temperature, on the Agilent eclipse C18 column (150 × 4.6 mm, 3.5 μ). The PDA detectors instrumental settings included a wavelength of 225 nm. The separation of Opicapone and its impurities required a 20-minute run time. The new approach was tested according to the guidelines of the International Conference on Harmonization. Limit of quantification (LOQ) and Limit of detection (LOD) were determined with regard to test concentration for the Opicapone and its contaminants. Parameters like specificity, linearity, accuracy, ruggedness, and robustness were examined as a part of the technique validation process, and the results were determined to be within permissible limits. Hence, this method is a greener and used for the detection of impurities (i.e, Opicapone and its related impurities).
Key words: Opicapone, Related impurities, HPLC, Development, Validation
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