The present work describes the development and validation of a simple, rapid, selective and reproducible RP-HPLC method for the Analysis of Tadalafil in Bulk, tablets and In-Vitro Dissolution Samples. Analysis was performed on an Agilent, EclipseC18 column (150 mm × 4.6 mm, 5 𝜇m) with the mobile phase consisting of ammonium acetate (10 mM):methanol (35:65v/v) at a flow rate of 1.0 mL/min. UV detection was performed at 280 nm and the retention time for TDL was 4.6 minutes. The dissolution media composed of 0.5% SLS, using USP II (Paddle) Dissolution apparatus, at 50 RPM and temperature maintained 37.0 ± 0.5ͦ C. The method was validated according to ICH guidelines.
The method was validated for specificity, accuracy, precision, ruggedness, limit of quantification, limit of detection and linearity. The system suitability parameters, such as , tailing factor, theoretical plate and relative standard deviation (RSD) for assay of five standard replicates, were well within the limits. The results of the studies showed that the proposed RP-HPLC method is simple, rapid, precise and accurate. Hence the method can be used for the routine Dissolution Profiling of Tadalafil as well as its assay in bulk and tablets .
Key words: Dissolution study, Method Validation, PDA Detector, Reverse-Phase High Performance Liquid Chromatography, Tadalafil.
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