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Abstract

DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING UV SPECTROSCOPIC METHOD FOR PALBOCICLIB WITH FORCED DEGRADATION STUDIES

Syeda Kulsum*, Ayesha Naz, Amena Samreen, Umme Haani Binte Abdullah, Bushra Khatoon, Bushra Fatima and Fatima Zahed.

MRM College of Pharmacy, Ibrahimpatnam, Hyderabad.

ABSTRACT

Palbociclib is a selective cyclin-dependent kinase (CDK) 4/6 inhibitor indicated for the treatment of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer. The present study aimed to develop and validate a simple, accurate, precise, and stability-indicating UV–Visible spectrophotometric method for the quantitative estimation of Palbociclib in capsule dosage form according to International Council for Harmonisation (ICH) guidelines. Forced degradation studies were also performed to evaluate the stability profile of the drug under different stress conditions. Palbociclib standard and capsule formulations were analyzed using a Shimadzu UV–Visible spectrophotometer with 0.1 N hydrochloric acid as the solvent. The absorption spectrum was scanned between 200 and 400 nm, and the maximum absorbance (λmax) was observed at 258 nm. Calibration standards ranging from 5–30 µg/mL were prepared, and the analytical method was validated for linearity, accuracy, precision, limit of detection (LOD), and limit of quantification (LOQ). Stability-indicating capability was evaluated through acid, alkaline, oxidative, thermal, and photolytic degradation studies. The developed method exhibited excellent linearity over the concentration range of 5–30 µg/mL with a regression equation of y = 0.020x + 0.001 and a correlation coefficient close to 0.999. It is suitable for routine quantitative estimation of Palbociclib in capsule dosage forms and can be effectively employed in quality control laboratories for routine pharmaceutical analysis and stability evaluation.

Keywords: Palbociclib, UV–Visible spectroscopy, Method validation, Stability-indicating method, Forced degradation, ICH guidelines.


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