RP-HPLC Method Development and Validation of Tadalafil in Tablet Dosage form

Tadalafil is a phosphodiesterase 5 inhibitor accustomed to treat dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension. Tadalafil is an orally administered drug and it's marketed worldwide under the name Cialis. Analytical method development and validation play important roles within the discovery development and manufacture of pharmaceuticals. These methods is to make sure the identity, purity, potency, and performance of drug product. The bulk of the analytical development effort goes into validating a stability indicating HPLC–method. Analytical method development could be a process of proving that the developed chromatography method is suitable for its intended use within the development and manufacturing of the pharmaceutical drug substance and drug product. All analytical methods that are intended to be used for analyzing any clinical samples will have to be validated. The target of the strategy validation is to demonstrate that the strategy is suitable for its intended purpose because it is stated in ICH guidelines.