Analytical Method Development and Validation of Palbociclib in Its Pure Dosage Forms

K. Nithiyananthan^1*, K.V.S Prasadarao^2
1Research Scholar, Acharya Nagarjuna University, Guntur.
²Principal, Rahul Institute of Pharmaceutical Sciences and Research, Chirala.

A  B  S  T  R A C T
A simple, rapid, and robust RP-HPLC method have been developed and validated to measure Palbociclib at single wavelength (320nm). An isocratic elution of samples performed on YMC C18 column (4.6×150mm) 5µ, flow rate was 0.6 ml/min, mobile phase ratio was Water: meoH (20:80%v/v).The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, photodiode array detector 996, Empower-software version-2. The retention times were found to be 2.497 mins. The % purity of Palbociclib was found to be 99.94%.The system suitability parameters for Palbociclib such as theoretical plates and tailing factor were found to be 4187, 1.5. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Palbociclib was found in concentration range of 20µg-100µg and correlation coefficient (r²) was found to be 0.999, % recovery was found to be 99.95%, %RSD for repeatability was 0.24, % RSD for intermediate precision was 0.15. The precision study was precision, robustness and repeatabilty.LOD value was 3.04 and LOQ value was 10.14.
Keywords: YMC C18 column, Palbociclib, RP-HPLC.