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Purpose <p>This study presents a novel testing application for simultaneous estimation of biguanide with two different drug classes, sulfonylurea and sodium-glucose co-transporter 2(SGLT2) inhibitors in tablet dosage form. The focus was to quantitate all three drugs in single run on newer chemistry column, additive free mobile phase, using greener solvent and covering wide concentration range.</p> Method <p>This chromatographic method was established on non-conventional C18- embedded polar shielding(EPS) reversed-phase column and a simple mobile phase. The method operated at a column flow rate of 0.8 mL min − 1 with a UV detector at 225&#xa0;nm. The retention times of Metformin(MTH), Glimepiride(GPD) and Canagliflozin(CGF) are about 6.5, 9.2 and 13.2&#xa0;min respectively with 20&#xa0;min runtime. The method is sustainable and aligned with most of the principles of green analytical chemistry (GAC). It is environmentally responsible, developed with excellent performance for most metrics of greenness indicated by AGREE score 0.73, BAGI score 80.0, AGREE-Prep score 0.73, MoGAPI score 80 and RAPI score 70.0. A standardized testing protocol was set for estimating three prominent antidiabetic drugs. Furthermore, it helps to overcome difficulty in estimating low-dose Glimepiride and inconsistent regulatory enforcement.</p> Results <p>The validated method exhibited excellent linearity within 50–150% of the target concentration with correlation coefficients (r) &gt; 0.99 for all analytes. The LOD values of MTH, GPD and CGF are 5.96, 0.10 and 0.97&#xa0;µg/mL and LOQ values are 18.05, 0.29 and 2.93&#xa0;µg/mL respectively. Accuracy studies showed overall mean recoveries of 99.5% for MTH, 100.1% for GPD and 100.2% for CGF.</p> Conclusion <p>The method is precise, accurate, and offering an efficient analytical approach for simultaneous estimation of three drugs in fixed-dose formulations. It exemplifies the sustainable solvent selection and resource-efficient analytical practices integrated to deliver an accessible greener method.</p>

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An Efficient Green HPLC Approach for Simultaneous Analysis of Hydrophilic and Lipophilic Drugs on Polar Stationary Phase

  • 期刊论文

  • 发表日期：

    2026年6月26日

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  • Mrunalini D. Kulkarni,
  • Mukesh Lahu Parab

摘要

Purpose

This study presents a novel testing application for simultaneous estimation of biguanide with two different drug classes, sulfonylurea and sodium-glucose co-transporter 2(SGLT2) inhibitors in tablet dosage form. The focus was to quantitate all three drugs in single run on newer chemistry column, additive free mobile phase, using greener solvent and covering wide concentration range.

Method

This chromatographic method was established on non-conventional C18- embedded polar shielding(EPS) reversed-phase column and a simple mobile phase. The method operated at a column flow rate of 0.8 mL min − 1 with a UV detector at 225 nm. The retention times of Metformin(MTH), Glimepiride(GPD) and Canagliflozin(CGF) are about 6.5, 9.2 and 13.2 min respectively with 20 min runtime. The method is sustainable and aligned with most of the principles of green analytical chemistry (GAC). It is environmentally responsible, developed with excellent performance for most metrics of greenness indicated by AGREE score 0.73, BAGI score 80.0, AGREE-Prep score 0.73, MoGAPI score 80 and RAPI score 70.0. A standardized testing protocol was set for estimating three prominent antidiabetic drugs. Furthermore, it helps to overcome difficulty in estimating low-dose Glimepiride and inconsistent regulatory enforcement.

Results

The validated method exhibited excellent linearity within 50–150% of the target concentration with correlation coefficients (r) > 0.99 for all analytes. The LOD values of MTH, GPD and CGF are 5.96, 0.10 and 0.97 µg/mL and LOQ values are 18.05, 0.29 and 2.93 µg/mL respectively. Accuracy studies showed overall mean recoveries of 99.5% for MTH, 100.1% for GPD and 100.2% for CGF.

Conclusion

The method is precise, accurate, and offering an efficient analytical approach for simultaneous estimation of three drugs in fixed-dose formulations. It exemplifies the sustainable solvent selection and resource-efficient analytical practices integrated to deliver an accessible greener method.