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Abstract <p>The current study presents the development and validation of a ultraviolet-visible (<b>UV-Vis</b>) spectroscopic method for the quantification of pregabalin in its bulk and marketed formulations. To perform this study, pregabalin was first derivatized by conducting a conventional diazotization procedure and then coupled with β-naphthol at 2–5°C. The formed adduct showed its highest absorption maximum at 355 nm within the range of 200–800 nm on the UV-Vis spectrum. Further, the developed method was validated as per International Council for Harmonization guidelines. The method was linear over the concentration range of 0.06 to 0.24 µg/mL (<i>r</i><sup>2</sup> = 0.9971), with limits of detection (0.001 µg/mL) and quantitation (0.003 µg/mL). Intra-day (mean recovery of 99.5%) and inter-day (mean recovery of 99.9%) precision were determined. The mean recovery in the accuracy study was between 99.7–100.4%. The method showed superiority over all the previously reported methods, featuring a rapid reaction, simplistic synthesis, shorter analysis time, and high sensitivity. Additionally, the method proved successful when applied to the quantification of marketed products.</p>

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Determination of Pregabalin in Bulk and Capsule Samples Using Diazotization and Azo Coupling Reactions and Ultraviolet-Visible Spectrophotometry

  • 期刊论文

  • 发表日期：

    2026年3月1日

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  • Niralee J. Malviya,
  • Mohammed Alqarni,
  • Abdullah A. Alshehri,
  • Hardik L. Varu,
  • Mrunal A. Ambasana

摘要

Abstract

The current study presents the development and validation of a ultraviolet-visible (UV-Vis) spectroscopic method for the quantification of pregabalin in its bulk and marketed formulations. To perform this study, pregabalin was first derivatized by conducting a conventional diazotization procedure and then coupled with β-naphthol at 2–5°C. The formed adduct showed its highest absorption maximum at 355 nm within the range of 200–800 nm on the UV-Vis spectrum. Further, the developed method was validated as per International Council for Harmonization guidelines. The method was linear over the concentration range of 0.06 to 0.24 µg/mL (r2 = 0.9971), with limits of detection (0.001 µg/mL) and quantitation (0.003 µg/mL). Intra-day (mean recovery of 99.5%) and inter-day (mean recovery of 99.9%) precision were determined. The mean recovery in the accuracy study was between 99.7–100.4%. The method showed superiority over all the previously reported methods, featuring a rapid reaction, simplistic synthesis, shorter analysis time, and high sensitivity. Additionally, the method proved successful when applied to the quantification of marketed products.