Tadalafil Review on Analytical Methods Developed for Pharmaceutical Formulations
Abstract
Tadalafil is a phosphodiesterase- 5 (PDE- 5) inhibitor that has been well-known in the treatment of erectile dysfunction, pulmonary arterial hypertension, and benign prostate hyperplasia. The growing clinical use of tadalafil has led to the need to identify effective analytical mechanisms to determine the drug in the pharmaceutical preparations and in the biological samples. Some of the analytical methods that have been reported in the determination of tadalafil include UV-visible spectrophotometry, high-performance liquid chromatography (HPLC), reverse phase high-performance liquid chromatography (RP-HPLC), high-performance thin-layer chromatography (HPTLC), ultra-performance liquid chromatography (UPLC), liquid chromatography-mass spectrometry (LC-MS), and electrochemical. RP-HPLC is the most commonly used one of these because it has high sensitivity, precision, strength, and can be used in routine quality control. Recent developments in analytical chemistry focus on green analytical methods, chemometric optimization, and Analytical Quality by Design (AQbD) methods to improve the performance of methods and regulatory discipline. The review outlines the different analytical methods which have been described in the determination of tadalafil in pharmaceutical dosage forms and key aspects of the methods, chromatographic conditions, validation parameters, benefits and limitations. The paper also addresses the new trends in the field of analytical analysis and views on…
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