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<p>A fixed-dose combination of Empagliflozin and Metoprolol succinate is used to treat type 2 diabetes mellitus and can also help to manage blood pressure and cardiovascular risks. The research article aims to develop and validate a UV-spectrophotometric method for the simultaneous estimation of Empagliflozin and Metoprolol succinate. The present research includes a Q-Point absorption UV method for the determination of drug combination in synthetic mixture. Empagliflozin and Metoprolol succinate show an isoabsorptive point at 214&#xa0;nm in methanol. The second wavelength used is 224&#xa0;nm, which is the λ-max of Empagliflozin in methanol. The linearity was obtained in the concentration range of 4.8–7.2&#xa0;µg/ml for Empagliflozin and 12–18&#xa0;µg/ml for Metoprolol succinate. The method was successfully applied to tablet dosage form because no interference from the tablet excipients was found. The devised method was validated in accordance with the ICH Q2(R2) standard. Statistical testing using an Analysis of Variance test revealed no significant differences in precision. The new UV spectrophotometric method’s ecological impact was evaluated using the software-based Analytical Greenness Metric (AGREE) tool. In terms of solvent use, chemical compounds, energy consumption, and waste production, this evaluation validated the method’s environmental friendliness. Empagliflozin and Metoprolol succinate in combination dose form can be properly analyzed using both techniques without excipient influence.</p>

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Green UV-spectrophotometric method development and validation for Empagliflozin and Metoprolol succinate from combined pharmaceutical dosage form

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月9日

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  • Priyanka Patil,
  • Hitanshi Darji,
  • P. N. Sable

摘要

A fixed-dose combination of Empagliflozin and Metoprolol succinate is used to treat type 2 diabetes mellitus and can also help to manage blood pressure and cardiovascular risks. The research article aims to develop and validate a UV-spectrophotometric method for the simultaneous estimation of Empagliflozin and Metoprolol succinate. The present research includes a Q-Point absorption UV method for the determination of drug combination in synthetic mixture. Empagliflozin and Metoprolol succinate show an isoabsorptive point at 214 nm in methanol. The second wavelength used is 224 nm, which is the λ-max of Empagliflozin in methanol. The linearity was obtained in the concentration range of 4.8–7.2 µg/ml for Empagliflozin and 12–18 µg/ml for Metoprolol succinate. The method was successfully applied to tablet dosage form because no interference from the tablet excipients was found. The devised method was validated in accordance with the ICH Q2(R2) standard. Statistical testing using an Analysis of Variance test revealed no significant differences in precision. The new UV spectrophotometric method’s ecological impact was evaluated using the software-based Analytical Greenness Metric (AGREE) tool. In terms of solvent use, chemical compounds, energy consumption, and waste production, this evaluation validated the method’s environmental friendliness. Empagliflozin and Metoprolol succinate in combination dose form can be properly analyzed using both techniques without excipient influence.