Ultra performance liquid chromatographic method for simultaneous quantification of plerixafor and related substances in an injection formulation

Abstract

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.

Keywords:

• plerixafor
• potential impurities
• UPLC
• stability-indicating assay
• validation

Public Interest Statement

For a medicinal drug to be proven safe and effective, it must be tested for various quality attributes before releasing into the market. Since most of the drugs are synthesized chemically and contain certain impurities which are clinically not safe for human body. Different drug regulations require identification and quantification of these impurities and control below a safety threshold limits. The techniques associated with these estimations involve intensive testing and take time to release the product into the market and in the process eliminate lots of organic wastes.

This research was aimed to develop new shorter procedures of testing on the same technique for a quick testing of the product at the quality control lab and release into the market. In this research, Plerixafor a cancer drug can be tested in 9 min for critical quality attributes like amount of main drug and impurities. As a result of reduced time, solvent usage is also reduced.

Acknowledgments

The authors wish to thank the management of Mylan Laboratories Ltd for supporting this work. We would also like to thank colleagues in the analytical development services for their co-operation in carrying out this work.

Additional information

Funding

Funding. This work was supported by the Mylan Laboratories Ltd.

Notes on contributors

G. Venkata Narasimha Rao

G. Venkata Narasimha Rao received the Bachelor of Science (BSc), Master of Science (MSc-Applied Chemistry) degrees from the Acharya Nagarjuna University of Guntur, Devi Ahilya University of Indore, India, respectively. During 2007-up to date, he is working as an analytical scientist with a designation of Associate Director, in Mylan Laboratories Ltd. He is presently perusing his research in developing shorter chromatographic methods for various pharmaceutical drug products, especially cancer therapeutic drugs, by exploring the supercritical fluid chromatography and associated techniques. His research interests are aimed at reducing the analysis time and the solvent consumption for a better waste management and safeguard of the environment.