A novel, reversed-phase high-performance liquid chromatographic method was developed and validated for the Assay of Plerixafor (PLX) drug substance. PLX is an immune stimulant used to mobilize hematopoietic stem cells in cancer patients. The method was developed using Agilent Zorbax Eclipse plus C18 column using the 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 of ion-pair reagent in the separation of polar compounds. PLX was subjected to various stress conditions of oxidative, acid, base, hydrolytic, thermal, humidity and photolytic degradations. The degradation products were well separated from each other and with the main peak, demonstrating the stability-indicating power of the method. The performance of the method was validated according to the present ICH guidelines for specificity, limit of detection, limit of quantification, linearity, accuracy, precision, ruggedness and robustness.
K. Pravalika1*, A. Sravani2, Kanti Silpa3, Dr. P. Shyamala3, A. V. A. N. Haritha4, Dr. G. Haritha5 (Mon,) studied this question.