ANALYTICAL METHOD VALIDATION FOR THE ASSAY OF FINASTERIDE BY HPLC

Abstract

A reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the determination of purity of Finasteride using 3.0mm x 3.0cm, 3µm Packing L7 or quivalent column maintained at 25°C with a mobile phase of a water and tetrahydrofuran (4:1). The mobile phase flow rate was 3.0 mL/min, and the detection wavelength was 215 nm. The developed HPLC method was validated with respect to linearity, accuracy, precision, specificity, and robustness. The developed HPLC method to determine the assay of Finasteride can be used to evaluate the quality of regular production samples. It can be also used to test the stability samples of Finasteride.