Sustainable UV approaches supported by greenness and whiteness assessments for estimating a recently FDA-approved combination for managing urologic disorders: Tukey's test

Abstract

Erectile dysfunction caused by a urinary tract infection and an enlarged prostate is a common problem among men nowadays. A brand-new FDA-approved combination of finasteride (FNS) and tadalafil (TDF) is currently recommended, particularly for those with prostatic problems in addition to erectile dysfunction. TDF boosts FNS's short-term efficacy in addition to treating erectile dysfunction, one of the sexual adverse effects typically associated with FNS therapy. Accordingly, this research introduces three straightforward spectrophotometric techniques for determining FNS and TDF in their pure and pharmaceutical forms concurrently, in addition to providing a dissolution study for their formulation as per the FDA’s directions. FNS and TDF have superimposed UV spectra, making direct concurrent analysis of these medications impossible. To resolve this overlap, we utilized the following UV techniques: the dual-wavelength method, the deconvoluted Fourier method, and the ratio difference method, with linear ranges of (0.50–15) µg/mL for TDF and (5–100) µg/mL for FNS. The LODs ranged from (0.12–0.15) µg/mL and (0.88–1.14) µg/mL, while the LOQs ranged from (0.37–0.46) µg/mL and (2.66–3.45) µg/mL for TDF and FNS, respectively. The proposed techniques were verified as per ICH recommendations and compared statistically to the published approach using three statistical tests. A complete green profile was provided to assess the foregoing techniques’ greenness using four metrics, along with the whiteness assessment using the RGB algorithm. The foregoing UV methods have been demonstrated to be sustainable, highly sensitive, specific, and suitable for quality assurance testing.