Abstract

K. Pravalika*, A. Sravani, Kanti Silpa, Dr. P. Shyamala, A. V. A. N. Haritha, Dr. G. Haritha

ABSTRACT

A novel, reversed-phase high-performance liquid chromatographic method wasdeveloped and validated for the Assay of Plerixafor (PLX) drug substance. PLX isan immune stimulant used to mobilize hematopoietic stem cells in cancer patients.The method was developed using Agilent Zorbax Eclipse plus C18 column usingthe isocratic program with mobile phase as a mixture of buffer and acetonitrile(65:35) v/v. PLX is monitored at 210 nm. The present work is describing the role ofion-pair reagent in the separation of polar compounds. PLX was subjected tovarious stress conditions of oxidative, acid, base, hydrolytic, thermal, humidity andphotolytic degradations. The degradation products were well separated from eachother and with the main peak, demonstrating the stability-indicating power of themethod. The performance of the method was validated according to the present ICHguidelines for specificity, limit of detection, limit of quantification, linearity,accuracy, precision, ruggedness and robustness.