A Novel Stability-Indicating RP-HPLC Method for the Simultaneous Determination of Palbociclib and Its Impurities in API and Pharmaceutical Dosage Forms
Abstract
In this present study, it is developed and validated a novel RP-HPLC method has been developed and validated for quantifying Palbociclib and its associated impurities in both active pharmaceutical ingredient (API) and finished dosage forms. The method enables the simultaneous determination of assay and related substances and is distinguished by its accuracy, specificity, selectivity, simplicity, and precision. With six specified impurities present in Palbociclib, the method offers a reliable and efficient approach for their determination. Using a YMC Triart C18 column, Palbociclib and its impurities were effectively separated. During the gradient phase, acetonitrile and orthophosphate buffer were used as the mobile phase. With a total run time of 60 minutes and a column temperature of 30°C, detection was carried out at 230 nm. Over the concentration range of 0.5–200 g/mL, the method demonstrated linearity. The method was validated according to ICH guidelines, and forced degradation studies confirmed its stability-indicating characteristics. According to the developed method, it is specific, selective, precise, accurate, and robust, so it can be used in routine quality control analysis
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