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August 14, 2026Analytical Chemistry Letters

Lean six sigma driven green HPLC method for determination of paracetamol, phenylephrine hydrochloride, caffeine and diphenhydramine hydrochloride in pharmaceutical combination

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Authors

SYSuvarna YendurıKVKG VenkateshNKNaga Prashant K

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Overview

Experimental study demonstrates successful optimization and validation of a green HPLC method for four-drug tablets, suggesting an eco-friendly approach for routine quality control.

Key Points

  • Develop and validate an efficient, eco-friendly Lean Six Sigma-based RP-HPLC method for simultaneous quantification of paracetamol, phenylephrine hydrochloride, caffeine, and diphenhydramine hydrochloride in tablet formulations.
  • Applied a Lean Six Sigma framework with Box–Behnken Design to optimize chromatographic parameters using a Zorbax Eclipse plus C18 column.
  • Established a mobile phase consisting of ethanol and 0.1% formic acid at a flow rate of 1.5 mL/min with UV detection at 218 nm.
  • Validated the analytical procedure per ICH Q2 guidelines, including evaluations of linearity, limits of detection, sustainability, and process capability (Cpk).
  • Achieved a linear range of 2–150 µg/mL for all four compounds, with limits of detection of 0.6503 µg/mL (phenylephrine), 0.6541 µg/mL (paracetamol), 0.3786 µg/mL (caffeine), and 0.6056 µg/mL (diphenhydramine).
  • Confirmed all validation parameters satisfied ICH Q2 criteria, with Cpk metrics demonstrating high process capability alongside improved environmental sustainability.

Cite This Study

Yendurı et al. (2026) studied this question.

synapsesocial.com/papers/6a7ec79cb70b84ec8b914182https://doi.org/10.1080/22297928.2026.2704078
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Also Consider

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