Validated Uv–Vis Spectrophotometric Method for Routine Quality Control Analysis of Tadalafil in Pharmaceutical Dosage Forms
Abstract
Objective: The goal of this study was to compare the assay values of branded and generic marketed formulations to assess their pharmaceutical equivalency and to develop, validate, and implement a straightforward, accurate, and the quantitative measurement of Tadalafil in pharmaceutical dosage forms and bulk drug samples has been accomplished by the development of a straightforward, affordable, and accurate UV-visible spectrophotometric technique. Method: Tadalafil solubility was first investigated in a range of solvents to identify a suitable dissolving media. By scanning drug solutions in the 200–400 nm range with ethanol and water as solvents, the wavelength of maximum absorbance (λmax) was found to be 285 nm. For calibration, standard stock solutions were made and diluted to values of 1–5 µg/mL. After recording absorbance values, a calibration curve was created. The developed method's linearity, accuracy, precision, and assay parameters were all evaluated. To ascertain the drug content, commercial tadalafil formulations (TADALAFIL, MEGALIS, and FORZEST) were examined. Result: The calibration curve showed good linearity with a regression coefficient (R2 = 0.999) in the concentration range of 1–5 µg/mL. Method repeatability was confirmed by intra-day and inter- day precision results with %RSD values below 2%, and accuracy studies with acceptable recovery values. According to assay results, the drug content of marketed tablets was 101.4% (TADALAFIL), 104.3% (MEGALIS), and…
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