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<p>The primary objective of the proposed study is to refine a novel, sensitive, rapid, eco-friendly, and specific HPLC method aimed at assessing the content of carbetocin in both raw materials and injectable solution. The optimized mobile phase employed was at a flow rate of 1&#xa0;mL/min, comprising 0.05&#xa0;M potassium phosphate monobasic buffer, pH 3.0, mixed with ethanol in a 75:25 (v/v) ratio (buffer:ethanol), with the detection wavelength at 220 nm, the injection volume was 50 µL, and the total analysis time was under 7.5&#xa0;min. The calibration curve concentrations for carbetocin ranged from 0.5 to 100&#xa0;µg/mL. The resulting sustainability scores are as follows: 0.6 for AGREEprep (Analytical Greenness Metric for Sample Preparation), 72.22 for AGSA (Analytical Green Star Area), 80 for BAGI (Blue Applicability Grade Index), 78 for CACI (Click Analytical Chemistry Index), 88 for CaFRI (Carbon Footprint Reduction Index), 85.5 for the AES (Analytical Ecoscale), 80 for MoGAPI (Modified Green Analytical Procedure Index), while an (A) letter score of 80.0% indicates the whiteness level using the Multi-color Assessment (MA) Tool. Collectively, these findings highlight the high sustainability, ecological friendliness, brightness, and economic viability of the methodology. All validation parameters adhered to the international ICH and US FDA validation standards. This approach provides numerous benefits, including reduced retention time, minimized reagent consumption, concurrent analysis capabilities, and lower expenses when compared to more complex systems such as UPLC-MS.</p> Graphical Abstract <p></p>

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An Environmentally Friendly, Dependable, and Stability-Indicating Approach for Hormone Regulation in Injectable Drugs Utilizing Microscale Sample Preparation

  • 期刊论文

  • 发表日期：

    2026年6月27日

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  • Xiao-Chen Huang,
  • Ri-Meng Chen,
  • Ahmed Sobhy Darwish,
  • Nan Zhang

摘要

The primary objective of the proposed study is to refine a novel, sensitive, rapid, eco-friendly, and specific HPLC method aimed at assessing the content of carbetocin in both raw materials and injectable solution. The optimized mobile phase employed was at a flow rate of 1 mL/min, comprising 0.05 M potassium phosphate monobasic buffer, pH 3.0, mixed with ethanol in a 75:25 (v/v) ratio (buffer:ethanol), with the detection wavelength at 220 nm, the injection volume was 50 µL, and the total analysis time was under 7.5 min. The calibration curve concentrations for carbetocin ranged from 0.5 to 100 µg/mL. The resulting sustainability scores are as follows: 0.6 for AGREEprep (Analytical Greenness Metric for Sample Preparation), 72.22 for AGSA (Analytical Green Star Area), 80 for BAGI (Blue Applicability Grade Index), 78 for CACI (Click Analytical Chemistry Index), 88 for CaFRI (Carbon Footprint Reduction Index), 85.5 for the AES (Analytical Ecoscale), 80 for MoGAPI (Modified Green Analytical Procedure Index), while an (A) letter score of 80.0% indicates the whiteness level using the Multi-color Assessment (MA) Tool. Collectively, these findings highlight the high sustainability, ecological friendliness, brightness, and economic viability of the methodology. All validation parameters adhered to the international ICH and US FDA validation standards. This approach provides numerous benefits, including reduced retention time, minimized reagent consumption, concurrent analysis capabilities, and lower expenses when compared to more complex systems such as UPLC-MS.

Graphical Abstract