Plerixafor (PLX) injections are administered to patients with cancers of lymphocytes (non-Hodgkin’s lymphoma) and plasma cells (multiple myeloma). The main objective of the current study was to develop a short reverse phase chromatographic method for the simultaneous quantification of PLX and its impurities, in an injection formulation, to reduce the time required for these quality tests. Furthermore, the present work describes the role of nonalkyl branched nonquaternary ion pair reagent in improving the peak shape and reducing column equilibration time. The separation of PLX and its related substances is pH dependent (optimum pH = 2.50) and was achieved on an octadecylsilyl (C18) column. The method was validated for its intended purpose in accordance with the current regulatory guidelines for validation. The proposed method can be applied for quality control, release, and stability analyses of active pharmaceutical ingredient, PLX, as well as finished products, PLX injections.
Comments: 14 Pages. OK
[v1] 2019-05-19 04:55:23
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