Abstract

A REVIEW ON ANALYTICAL METHOD DEVELOPMENT FOR SIMULTANEOUS ESTIMATION AND VALIDATION OF FINASTERIDE AND TADALAFIL

Tejal K. Dabhi* and Vipul M. Vaghela

Abstract

Finasteride is a 5α-reductase inhibitor and therefore an antiandrogen. It works by decreasing the production of dihydrotestosterone (DHT) by about 70%, including in the prostate gland and the scalp. In addition to DHT, finasteride also inhibits the production of several anticonvulsant neurosteroids including allopregnanolone, and rostanediol, and THDOC (Tetrahydroxycorticosteroid). Finasteride has been used for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate and for the treatment of male pattern hair loss (androgenetic alopecia) in men. Finasteride may improve the symptoms associated with BPH such as difficulty urinating, getting up during the night to urinate, hesitation at the start and end of urination, and decreased urinary flow. Tadalafil is a PDE5 inhibitor which increases blood flow to the penis. It also dilates blood vessels in the lungs, which lowers the pulmonary artery pressure. Used to treat erectile dysfunction (ED), benign prostatic hyperplasia (BPH), and pulmonary arterial hypertension. Combination of tadalafil and finasteride is a safe, effective, and well tolerated treatment for BPH. This combination may be particularly effective in reducing treatment-related sexual adverse events associated with 5α-reductase inhibitor. This review includes various analytical methods for simultaneous estimation of finasteride and tadalafil. Various analytical methods were reported for determination of finasteride and for Tadalafil in bulk drug or in combination with other drugs. Till date there is only one UV spectrophotometric method and only one LC/MS method was reported for Finasteride and tadalafil in combined dosage form. This review can be used for further analytical method development.

Keywords: Benign Prostatic Hyperplasia (BPH), Finasteride, Tadalafil, Analytical Methods, Development, Validation.