Quality by design (QBD) based Development and Validation of RP-HPLC method for palbociclib in capsule dosage form

Abstract

A robust and reliable RP-HPLC method was developed and validated for the estimation of Palbociclib in bulk and pharmaceutical dosage forms, in accordance with ICH Q2(R1) guidelines. Method optimization using statistical design revealed that flow rate, buffer pH, and temperature significantly influenced chromatographic responses. Separation was achieved on an Intersil C18-EP column (4.6×250 mm, 5 µm) with a mobile phase of acetonitrile and phosphate buffer (70:30, pH 5) at a flow rate of 1.0 mL/min, detection at 270 nm, and injection volume of 20 µL. Palbociclib showed a sharp, symmetrical peak at ~3.3 min with excellent system suitability parameters (tailing factor ~1.1, plate count >6700).Validation studies confirmed the method’s performance, with linearity over 25–120 µg/mL (R² = 0.9999), high precision (%RSD < 1%), and accuracy with recoveries within 98–102%. Sensitivity was established with LOD 1.08 µg/mL and LOQ 3.62 µg/mL. Accuracy studies at multiple concentration levels yielded recoveries between 98.3–100.7%. Robustness testing showed no significant effect of small changes in flow rate and mobile phase composition on chromatographic performance. The developed RP-HPLC method is simple, precise, accurate, sensitive, and stability-indicating, making it suitable for routine quality control, batch release, and regulatory applications of Palbociclib formulations in the pharmaceutical industry.