Cutting-edge assays for mirabegron and tadalafil combo therapy for benign prostatic hyperplasia; insilico kinetics approach; multi trait sustainability assessment
Abstract
The combination therapy of mirabegron (MIR) and tadalafil (TAD) has gained significant attention in clinical practice for the treatment of Benign Prostatic Hyperplasia as well as overactive bladder syndrome. This study demonstrates the development and validation of two analytical methods for the concurrent determination of tadalafil and mirabegron in their synergistic combo therapy. Spectrophotometry and stability-indicating HPLC were employed for the accurate quantification of both drugs. The spectrophotometric methods were based on derivative, Fourier and ratio derivative of the two drugs, providing simpler, rapid alternatives for routine analysis. The stability-indicating HPLC method was developed using a reverse-phase column with a methanol-phosphate buffer gradient mobile phase, achieving optimal separation with detection at 250 nm for MIR and 225 nm for TAD. Forced degradation studies were performed under acidic, basic, oxidative, neutral, thermal, and photolytic conditions, confirming the method's ability to quantify MIR and TAD in presence of degradation products and establish drug stability. Both techniques were validated based on ICH guidelines, demonstrating excellent linearity, precision, accuracy, and sensitivity. The methods were successfully applied to the analysis of bulk powder and in dosage forms. Both methods were evaluated and found to be environmentally friendly, receiving approval as "green" according to the AGREE (Assessment Tool for Greenness) method,…
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