New stability-indicating liquid chromatographic method for determination of palbociclib (an anti-breast cancer drug)

Pramadvara Kallepalli


Introduction: A simple, sensitive stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for the determination of palbociclib. Palbociclib is an anticancer drug used for the treatment of breast cancer. It is a selective inhibitor of cyclin-dependent kinases. Materials and Methods: Waters Model 2695 alliance HPLC system (PDA Detector) with Inertsil ODS- 3V (4.6 mm × 250 mm, 5 µm) was used for the chromatographic separation. Mobile phase consisting of ammonium acetate:acetonitrile (32:68, v/v) was delivered at a flow rate of 1.0 ml/min (detection wavelength 263 nm) on isocratic mode for the chromatographic study. Results and Discussion: Palbociclib obeys Beer Lambert’s Law over a concentration range 5–1000 µg/ ml. The limit of detection and limit of quantification are found to be 1.6378 and 4.951 µg/ml. The method was validated as per the ICH guidelines. Forced degradation studies were conducted, and the method was found to be specific. Conclusion: The present RP-HPLC method is simple, precise, and accurate and can be used for the routine analysis of pharmaceutical formulations.

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