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<p>Genotoxic impurities cause mutations and also result in cancer. SDG3 (Good Health and Well-Being), Targets 3.8 and 3.d. were achieved in the current method by establishing potential genotoxicity of the selected impurities based on (Q)-SAR methodologies. SDG9 (Industry, Innovation, and Infrastructure), Target 9.4 was realized by developing a simple and straightforward UPLC-APCI-MS/MS method for simultaneous quantification of four genotoxic impurities (2-aminophenol, 3-aminophenol, 4-choroanilline, and 4,4’-oxydianiline) in Acetaminophen API – an analgesic and antipyretic medication, and validated as per ICH (Q2 R2) guidelines. Optimized conditions are column (Agilent Poroshell EC C18, 100&#xa0;mm x 4.6&#xa0;mm, 2.7&#xa0;μm), flow rate (0.7 mL/min), a gradient elution method with a mixture of two mobile phases (A: 5 mM ammonium acetate buffer, pH adjusted to 5.0, and B: 100% Methanol). MRM (multiple reaction monitoring) was used in atmospheric pressure chemical ionization positive mode for data acquisition. Up to a concentration of 0.11 ppm, these four impurities (2-aminophenol, 3-aminophenol, 4-chloroaniline, and 4,4’-oxydianiline) can be quantified by using the current method. A good linearity was exhibited by the calibration curves with higher correlation coefficients (more than 0.995) over a concentration ranging from LOQ to 150% of the specification limit. For all selected impurities, satisfactory recoveries were observed in the range of 73.53 and 125.37%. Assessed the method’s eco-friendliness by greenness tools like the Green Analytical Procedure Index (GAPI), Analytical GREEnness (AGREE), and Analytical Eco-Scale, and found it to be eco-friendly.</p> Graphical Abstract <p></p>

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Potential Genotoxic Impurities Determination in Analgesic and Antipyretic Medication – Acetaminophen: (Q)SAR Assessment, UPLC-APCI-MS/MS Method Development, Validation, and Its Analytical Greenness Evaluation

  • 期刊论文

  • 发表日期：

    2026年1月22日

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  • Sriram Pepakayala,
  • Venkata Nadh Ratnakaram,
  • Yuvaraj Zunjarrao,
  • Krishna Kumar A. Yadav

摘要

Genotoxic impurities cause mutations and also result in cancer. SDG3 (Good Health and Well-Being), Targets 3.8 and 3.d. were achieved in the current method by establishing potential genotoxicity of the selected impurities based on (Q)-SAR methodologies. SDG9 (Industry, Innovation, and Infrastructure), Target 9.4 was realized by developing a simple and straightforward UPLC-APCI-MS/MS method for simultaneous quantification of four genotoxic impurities (2-aminophenol, 3-aminophenol, 4-choroanilline, and 4,4’-oxydianiline) in Acetaminophen API – an analgesic and antipyretic medication, and validated as per ICH (Q2 R2) guidelines. Optimized conditions are column (Agilent Poroshell EC C18, 100 mm x 4.6 mm, 2.7 μm), flow rate (0.7 mL/min), a gradient elution method with a mixture of two mobile phases (A: 5 mM ammonium acetate buffer, pH adjusted to 5.0, and B: 100% Methanol). MRM (multiple reaction monitoring) was used in atmospheric pressure chemical ionization positive mode for data acquisition. Up to a concentration of 0.11 ppm, these four impurities (2-aminophenol, 3-aminophenol, 4-chloroaniline, and 4,4’-oxydianiline) can be quantified by using the current method. A good linearity was exhibited by the calibration curves with higher correlation coefficients (more than 0.995) over a concentration ranging from LOQ to 150% of the specification limit. For all selected impurities, satisfactory recoveries were observed in the range of 73.53 and 125.37%. Assessed the method’s eco-friendliness by greenness tools like the Green Analytical Procedure Index (GAPI), Analytical GREEnness (AGREE), and Analytical Eco-Scale, and found it to be eco-friendly.

Graphical Abstract