RP-HPLC Method Development and Validation for Simultaneous Estimation of Tadalafil and Silodosin: A Comprehensive Review
Abstract
Benign Prostatic Hyperplasia (BPH) is a prevalent condition in aging men, often managed with pharmacological interventions. The fixed-dose combination of Silodosin, an alpha-1 adrenergic receptor antagonist, and Tadalafil, a PDE5 inhibitor, has gained regulatory approval for BPH management. This review highlights the principles of RP-HPLC method development and validation for simultaneous estimation of these drugs in pharmaceutical dosage forms. It emphasizes chromatographic optimization, stability-indicating approaches, and adherence to ICH guidelines, ensuring accuracy, precision, and robustness.
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