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Background <p>Paracetamol and Nefopam are commonly used analgesic agents, and their simultaneous estimation in human plasma is important for bioanalytical studies. A reliable and optimized analytical method is essential for accurate quantification of drugs in human plasma.</p> Objective <p>To develop and optimize a reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Paracetamol and Nefopam in spiked human plasma using a Quality by Design (QbD) approach.</p> Method <p>The method was developed using a QbD approach to optimize critical chromatographic parameters for improved resolution and reproducibility. Chromatographic separation was achieved on a C18 column using a mobile phase of acetonitrile (ACN) and 0.1% orthophosphoric acid (OPA) (80:20, v/v) at neutral pH in an optimized ratio, delivered at a flow rate of 0.7&#xa0;mL/min, with UV–Visible Multiple wavelength detector (MWD) at 255&#xa0;nm.</p> Results <p>The retention times for Paracetamol and Nefopam were approximately 6.220 and 7.410&#xa0;min, respectively, with good peak symmetry and resolution. The method showed good selectivity, linearity, accuracy, precision, recovery, and minimal matrix effect. A linear response was observed over 10 –50&#xa0;µg/mL for Paracetamol and 1–5&#xa0;µg/mL for Nefopam, with %RSD within acceptable limits. No significant plasma interference was observed.</p> Conclusion <p>The developed method is simple, reliable, and suitable for the routine analysis of Paracetamol and Nefopam in spiked human plasma, serving as a useful foundation for further bioanalytical studies.</p>

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RP-HPLC Method Development for Simultaneous Estimation of Paracetamol and Nefopam in Spiked Human Plasma Using a Design of Experiments Approach

  • 期刊论文

  • 发表日期：

    2026年5月20日

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  • Pratiksha R. Rajguru,
  • R. D. Chakole,
  • Indrajeet D. Gonjari,
  • Kiran R. Mali,
  • Deep M. Chaudhari,
  • Kajal S. Bansode

摘要

Background

Paracetamol and Nefopam are commonly used analgesic agents, and their simultaneous estimation in human plasma is important for bioanalytical studies. A reliable and optimized analytical method is essential for accurate quantification of drugs in human plasma.

Objective

To develop and optimize a reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Paracetamol and Nefopam in spiked human plasma using a Quality by Design (QbD) approach.

Method

The method was developed using a QbD approach to optimize critical chromatographic parameters for improved resolution and reproducibility. Chromatographic separation was achieved on a C18 column using a mobile phase of acetonitrile (ACN) and 0.1% orthophosphoric acid (OPA) (80:20, v/v) at neutral pH in an optimized ratio, delivered at a flow rate of 0.7 mL/min, with UV–Visible Multiple wavelength detector (MWD) at 255 nm.

Results

The retention times for Paracetamol and Nefopam were approximately 6.220 and 7.410 min, respectively, with good peak symmetry and resolution. The method showed good selectivity, linearity, accuracy, precision, recovery, and minimal matrix effect. A linear response was observed over 10 –50 µg/mL for Paracetamol and 1–5 µg/mL for Nefopam, with %RSD within acceptable limits. No significant plasma interference was observed.

Conclusion

The developed method is simple, reliable, and suitable for the routine analysis of Paracetamol and Nefopam in spiked human plasma, serving as a useful foundation for further bioanalytical studies.