Lean six sigma driven green HPLC method for determination of paracetamol, phenylephrine hydrochloride, caffeine and diphenhydramine hydrochloride in pharmaceutical combination
Year: 2026
Type: article
Abstract: The analytical methods used for simultaneous determination of multiple drugs should be reliable, efficient and eco-friendly unlike traditional methods. The study aimed to develop a Lean Six Sigma-based green RP-HPLC method to simultaneously determine phenylephrine hydrochloride, paracetamol, caffeine and diphenhydramine hydrochloride in tablets. The research utilized the Lean Six Sigma approach to develop the method, and Box–Behnken Design was applied to optimize chromatographic conditions and suggested ethanol and 0.1% formic acid as the mobile phase with a flow rate of 1.5 mL min-1, at λ of 218 nm using a Zorbax Eclipse plus C18 column. The method was validated according to ICH Q2 guidelines. The method sustainability and process capability were also assessed. All validation parameters are within the limits as per ICH Q2 guidelines with a linearity range of 2-150 µg/ mL for all drugs with an LOD of 0.6503 µg/mL for phenylephrine, 0.6541 µg/mL for paracetamol, 0.3786 µg/mL for Caffeine and 0.6056 µg/mL for diphenhydramine. The Cpk values demonstrated the full capacity of the method and greenness results indicated better environmental sustainability. The study developed a capable green HPLC method for routine quality control, providing a systematic framework for future green analytical method development.
Source: Figshare
Authors: Suvarna Yenduri, KG Venkatesh, Naga Prashant K
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W7202279327