Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF LAYER BY LAYER MAGNETIC NANOPARTICLES OF METHOTREXATE AND MELPHALAN

Subbarayan Shanmugavel *, Venkatachalam Karthikeyan

ABSTRACT

UV and HPLC analytical methods are developed and validated according to ICH guidelines to determine the drug loading capacity of layer by layer magnetic nanoparticles of Methotrexate and Melphalan. Both methods were very specific to the analyte(s) of interest and showed excellent linearity in the targeted range with more accurate and precise results. Robustness of the developed methods has been verified by making deliberate change in the methods. The change was not affect the accuracy and precision of the developed methods. Analyst to analyst variation was very less for both methods which revealed the ruggedness. Since the developed methods were met the validation criteria, it can be used for the intended purpose.

Keywords: Methotrexate, Melphalan, ICH, Method development and validation, Ultra Violet (UV) spectroscopy, HPLC, Simultaneous estimation.