Resumen de Rapid analysis of finasteride in bulk and formulations by rp-hplc-pda method

Sindhura Manne, Raghavi Kakarla, Prashanth Iraavi, Buchi N Nalluri

• A simple, precise, rapid and accurate LC-MS compatible RP-HPLC-PDA method has been developed and validated for the estimation of Finasteride (FIN) in bulk and tablet formulations. The chromatographic separation was achieved on Phenomenex C18 column (150 mm x 4.6 mm, 5.0 µ particle size) using the mobile phase comprising 0.02% formic acid (in water): methanol in the ratio of 20:80 (v/v) at a flow rate of 1mL/min and FIN was eluted at 3.4 min. Quantification and linearity were achieved at 220 nm over the concentration range of 5-50 µg/mL and the percentage mean of assay was found to be 100.29. The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ, stability and robustness as per the ICH guidelines and is suitable to be employed in Quality Control.