UV Spectrophotometric and UPLC assay methods for the determination of Palbociclib in bulk and Tablet Dosage Form

Abstract

The goal of this study was to create a sensitive and reliable UV-spectrophotometric and reverse phase liquid chromatographic method for determining Palbociclib in bulk and pharmaceutical dosage forms. The current UV approach uses methanol and phosphate buffer as a solvent to evaluate absorption at a maximum wavelength of 220nm. Waters Acquity BEH C18 (2.1 x 50mm, 1.7µm) UPLC column with Empower 2 was used in the UPLC procedure. The mobile phase was made up of 50:50 (v/v) methanol and phosphate buffer.The drug obeyed Beer Lambert's law in the UV technique in the concentration range of 1-70µg/ml with a regression coefficient of 0.999. The linearity level in the UPLC technique was 1-100µg/ml. In the validation investigation, the developed UV and UPLC procedures were successful. For the UPLC and UV methods, the percentage purity of the marketed dosage form of Palbociclib was found to be 98.76 percent and 98.84 percent, respectively. The percent RSD of all validation parameters investigated, as suggested by the ICH recommendations, was determined to be less than 2 in both techniques. The two methods established for determining Palbociclib in bulk and tablet doses were found to be accurate, simple, and validated.