• Dr. R. Suthakaran
• S. Janet Beula
• M. Suman Kumar

A simple, precise, and economical RP-HPLC method has been developed for simultaneous estimation of Letrozole and Palbociclib in bulk form and pharmaceutical formulation. RP-HPLC was developed using Phenomenex Luna C18, 100A, 5m, 250mmx4.6mm i.d.column, utilizing a mobile phase of Acetonitrile: Buffer (40:60) (pH-3.4 adjusted with orthophosphoric acid) (with a flow rate of 1.0ml/min) and U.V detection was carried out at 330nm. Optimization of this method was carried out as a function of mobile phase composition, pH, and flow rate. RP-HPLC method shows linearity in the range for 6-14μg/ml and 10-30μg/ml Letrozole and Palbociclib respectively. The LOD and LOQ values for Letrozole were 0.09µg/ml & 0.29μg/ml and 0.1µg/ml & 0.3µg/ml for Palbociclib respectively. The results of % purity were found to be 99.78(±0.48) /99.77(±0.12) for the HPLC method for Letrozole and Palbociclib respectively. Results of descriptive statistics studies conclude that the RP-HPLC method was found to be more sensitive and convenient for the estimation of method Letrozole and Palbociclib in bulk form and pharmaceutical formulation.

Letrozole and Palbociclib, RP-HPLC, Accuracy, Precision, ICH Guidelines.

"ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF LETROZOLE AND PALBOCICLIB BY USING RP-HPLC TECHNIQUE", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.8, Issue 9, page no.b385-b394, September-2021, Available :http://www.jetir.org/papers/JETIR2109145.pdf

"ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF LETROZOLE AND PALBOCICLIB BY USING RP-HPLC TECHNIQUE", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.8, Issue 9, page no. ppb385-b394, September-2021, Available at : http://www.jetir.org/papers/JETIR2109145.pdf