European Journal of Biomedical and Pharmaceutical Sciences

UV VISIBLE SPECTROPHOTOMETRIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF FINASTERIDE AND DUTASTERIDE

*Kavana M., Dr. S. Vijaya Bhaskar, Dr. Ayushi Chawla, Dr. Shachindra L Nargund, Nithya Shree H. P.

ABSTRACT

A simple, accurate, precise, and economical UV-visible spectrophotometric method was developed and validated for the simultaneous estimation of Finasteride and Dutasteride in bulk drug samples and pharmaceutical dosage forms. The method was developed according to International Council for Harmonisation guidelines. Methanol was selected as the solvent for the study of both drugs. Finasteride was having maximum absorbance at 240 nm, while Dutasteride was having maximum absorbance at 245 nm. The linearity range for both drugs was found to be 10–50 µg/mL with correlation coefficients of 0.9987 for Finasteride and 0.9999 for Dutasteride, indicating excellent linearity. Accuracy studies were performed by the recovery method at 80%, 100%, and 120% levels, and satisfactory percentage recoveries were obtained for both drugs. %RSD values of Precision studies, including intra-day and inter-day analysis were below 2%, confirming the reproducibility and reliability of the method. The developed method was successfully applied for the assay of tablet formulations of marketed products. The results demonstrated that the proposed UV spectrophotometric method is simple, sensitive, rapid, and suitable for routine quality control analysis of Finasteride and Dutasteride in pharmaceutical formulations.

Keywords: Dutasteride, Finasteride, Simultaneous Estimation, UV-Visible Spectrophotometry, Benign prostatic hyperplasia, ICH Guidelines.