title: Rapid Estimation of Tadalafil by Reverse-phase High-performance Liquid Chromatography Method in Bulk and Tablet Formulation.
abstract: The simple, selective, precise and accurate reverse-phase high-performance liquid chromatography method was developed and validated for analysis of tadalafil in bulk and tablet dosage form. The column was Inertsil C18 (150×4.6 mm; 5 μm) in isocratic mode. The mobile phase used was phosphate buffer (10 mM, pH 3.2) and acetonitrile (50:50% v/v) at the flow rate of 1.0 ml/min with ultraviolet detection at 295 nm at ambient temperature. The retention time for tadalafil was found to be 4.01 min. Linearity was observed in the concentration range from 60 to 140 μg/ml for tadalafil with a correlation coefficient of (r (2)) 0.9998. The method was validated according to International Conference on Harmonisation guidelines in terms of linearity, accuracy, precision and specificity. Hence, the proposed method can be utilized for routine quality control of tadalafil in bulk and tablet dosage form.
authors.affiliation: Department of Chemistry, Government College of Pharmacy, Osmanpura, Aurangabad-431 005, India.
authors.forename: P H
authors.initials: PH
authors.lastname: Sonawane
authors.forename: P S
authors.initials: PS
authors.lastname: Panzade
authors.forename: M A
authors.initials: MA
authors.lastname: Kale
keywords: International conference on harmonisation guidelines; reverse phase high performance liquid chromatography; tadalafil; ultraviolet detection; validation
references.citation: Talanta. 2005 Jan 15;65(1):276-80
references.pmid: 18969796