ASSAY METHOD DEVELOPMENT AND VALIDATION OF MINOXIDIL FILM-COATED TABLETS.

Abstract

A robust and precise reverse-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for the quantitative determination of Minoxidil in film-coated tablets. Chromatographic separation was achieved using an X-Bridge C18 column (150 mm x 4.6 mm ID, 5 μm). The mobile phase consisted of a buffer and acetonitrile mixture in a 55:45 (v/v) ratio. The diluent was prepared using water and acetonitrile in a 50:50 (v/v) ratio, while the needle wash solution was a 90:10 (v/v) acetonitrile-water mixture. The method employed a flow rate of 1.0 mL/min, a detection wavelength of 280 nm, an injection volume of 10 μL, and a column temperature of 40°C in isocratic pump mode. Minoxidil had a retention time of 6.6 minutes, with a total run time of 10 minutes. The assay exhibited a Minoxidil percentage range of 97%-102%, with an r² value of 1.000 for the concentration range tested. The %RSD values were less than 2%, indicating high accuracy and precision. The method demonstrated robustness within acceptable limits and was validated in accordance with ICH Q2 guidelines.