<p>Tadalafil and alfuzosin hydrochloride are frequently used together to treat benign prostatic hyperplasia. Recent approved combination of these medications was selected because only one study has investigated their synthetic mixture, and no research has examined the pharmaceutical dosage form using UV analysis. The purpose of this study is to create and verify a green UV spectrophotometric technique for the simultaneous measurement of tadalafil and alfuzosin hydrochloride in their combination dose form by developing two methods to ensure the lowest environmental impact, i.e., absorption correction method (method A) and the simultaneous equation method (method B). Tadalafil exhibited zero absorbance at 340 nm in method A, whereas alfuzosin hydrochloride exhibited absorption at 290 and 340 nm. Absorption maxima of 244 nm for alfuzosin hydrochloride and 283 nm for tadalafil are used in method B. A linear relationship in method A was found with correlation coefficient value of 0.999 for alfuzosin hydrochloride and 0.999 for tadalafil. While in method B, correlation coefficient of 0.999 and 0.996, respectively. All the validation parameters for the developed methods were found to be within the ICH guidelines' limits. The developed UV spectrophotometric method received an AGREEprep score of 0.81, MoGAPI score of 77 and BAGI score of 72.5. For routine quality monitoring of alfuzosin hydrochloride and tadalafil, this approach offers a straightforward, affordable, and environmentally friendly substitute that preserves analytical performance while promoting sustainable pharmaceutical analysis. If successfully implemented, it can help labs lessen their environmental impact without compromising the accuracy of their analyses.</p>

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Eco-Friendly Tandem Validated UV Spectrophotometric Methods for Estimation of Alfuzosin Hydrochloride and Tadalafil in Bulk and Combined Dosage Forms

  • D. V. Santhosh,
  • S. V. Kutty,
  • S. A. Surendran,
  • Y. Haribabu,
  • A. Hassanar,
  • A. Ashokan,
  • A. Aravind,
  • M. Absher

摘要

Tadalafil and alfuzosin hydrochloride are frequently used together to treat benign prostatic hyperplasia. Recent approved combination of these medications was selected because only one study has investigated their synthetic mixture, and no research has examined the pharmaceutical dosage form using UV analysis. The purpose of this study is to create and verify a green UV spectrophotometric technique for the simultaneous measurement of tadalafil and alfuzosin hydrochloride in their combination dose form by developing two methods to ensure the lowest environmental impact, i.e., absorption correction method (method A) and the simultaneous equation method (method B). Tadalafil exhibited zero absorbance at 340 nm in method A, whereas alfuzosin hydrochloride exhibited absorption at 290 and 340 nm. Absorption maxima of 244 nm for alfuzosin hydrochloride and 283 nm for tadalafil are used in method B. A linear relationship in method A was found with correlation coefficient value of 0.999 for alfuzosin hydrochloride and 0.999 for tadalafil. While in method B, correlation coefficient of 0.999 and 0.996, respectively. All the validation parameters for the developed methods were found to be within the ICH guidelines' limits. The developed UV spectrophotometric method received an AGREEprep score of 0.81, MoGAPI score of 77 and BAGI score of 72.5. For routine quality monitoring of alfuzosin hydrochloride and tadalafil, this approach offers a straightforward, affordable, and environmentally friendly substitute that preserves analytical performance while promoting sustainable pharmaceutical analysis. If successfully implemented, it can help labs lessen their environmental impact without compromising the accuracy of their analyses.