Development and Validation of a Simple Rp-hplc Method for the Estimation of Palbociclib in Bulk and Pharmaceutical Dosage Form

Author(s)	Dr. Syeda Kulsum, Dr. Ayesha Naz, Pittala Divya, Amena Samreen, Summaiya Tazbeen, Maheen Tazbeen, Syeda Samreen Farhana
Country	India
Abstract	A simple, accurate, and precise reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the estimation of Palbociclib in bulk and tablet dosage form. Chromatographic separation was achieved using a Waters HPLC system (Alliance 2695) equipped with a PDA detector and Symmetry ODS C18 column (4.6 mm × 150 mm, 5 µm). The mobile phase consisted of acetonitrile and methanol (60:40 % v/v) at a flow rate of 1.0 mL/min. Detection was carried out at 240 nm with an injection volume of 10 µl. The method was validated as per ICH Q2(R1) guidelines for linearity, accuracy, precision, and robustness. The method showed good linearity in the selected concentration range with acceptable correlation coefficient. The developed method was found to be simple, rapid, sensitive, and reproducible. Hence, the method can be successfully applied for routine analysis of Palbociclib in bulk and pharmaceutical dosage forms
Keywords	Palbociclib, RP-HPLC, Validation, ICH Q2(R1), Pharmaceutical Analysis
Field	Medical / Pharmacy
Published In	Volume 8, Issue 3, May-June 2026
Published On	2026-05-09
DOI	https://doi.org/10.36948/ijfmr.2026.v08i03.77702

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