Abstract

VALIDATED RP-HPLC METHOD FOR THE DETERMINATION OF PRALATREXATE IN BULK AND PHARMACEUTICAL DOSAGE FORMS.

*Syeda Kulsum and G Vidya Sagar

ABSTRACT

A simple, specific, precise, accurate, and sensitive Reverse Phase High Performance Liquid Chromatographic method has been developed for the determination of Pralatrexate in both pure and pharmaceutical dosage forms. In this method Agilent (4.6×150mm) 5μ column in isocratic mode with mobile phase containing water: methanol (25:75% v/v) was selected. The effluents were monitored at 300 nm and flow rate was fixed as 1.4 ml / min. The retention time was 3.312 min. The linearity was in the range of 20-100 g / ml. This method was validated for linearity, precision, limit of detection, limit of quantification and accuracy. Statistical analysis proves that the method is precise, reproducible and selective for the estimation of the pralatrexate drug.

Keywords: RP-HPLC, Pralatrexate, Validation.