article · Reviews in Analytical Chemistry
Researchers have developed an eco-friendly reversed-phase high-performance liquid chromatography method to determine the stability and presence of pimavanserin, a drug used to treat psychosis in Parkinson's disease. Using a Box-Behnken experimental design alongside Six Sigma lean techniques, the approach optimised chromatographic conditions while reducing waste. The separation was conducted on an Agilent Zorbax Eclipse Plus C18 column using ultraviolet detection at 226 nm, identifying an optimal mobile phase of buffer solution, acetonitrile, and tetrahydrofuran. The method exhibited high linearity across a concentration range of 3 to 50 micrograms per millilitre with a recovery rate of 101.30 per cent. Forced degradation testing conducted according to international guidelines revealed that pimavanserin is most vulnerable to oxidative hydrolysis and thermal breakdown.
Pimavanserin is essential for managing hallucinations and delusions associated with Parkinson's disease. Having precise, environmentally friendly testing methods ensures that commercial formulations of this medication remain potent, safe, and stable throughout their shelf life without relying on heavily polluting analytical procedures.
This technique offers an applied, validated testing protocol for pharmaceutical manufacturers and contract quality-control laboratories analysing pimavanserin pure forms and formulations. Given that it was tested under standard regulatory forced degradation conditions with established chromatographic equipment, the method appears ready for immediate operational adoption in pharmaceutical quality assurance and stability-testing workflows.
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Abstract A green analytical chemistry study attempts to generate environmentally friendly alternatives to dangerous compounds while reducing waste output. The study thoroughly analyzed eight green tools to determine their greenness. Given its importance in treating hallucinations and delusions produced by Parkinson’s disease psychosis, it is critical to have a reliable and precise method for identifying pimavanserin (PVS) in both pure form and pharmaceutical formulations. The current study used a straightforward approach to forced degradation experiments to establish a novel reversed-phase high-performance liquid chromatography method for evaluating stability. The method was executed on the Agilent Zorbax Eclipse Plus C18 column (100 × 4.6 mm, 3.5 μm particle size) with ultraviolet detection at 226 nm. The Box–Behnken design is the ultimate solution for identifying optimal chromatographic conditions in a timely and efficient manner, with minimal trials required. The study investigated the impact of three factors: acetonitrile ratio, column oven temperature, and flow rate on various responses, namely, retention time, tailing factor, and theoretical plates. Desirability and overlay plots were utilized to forecast the best mobile phase containing a buffer solution: acetonitrile: tetrahydrofuran in a ratio of (65: 20: 15, v/v/v), which proved highly effective in the experiments. Linearity was conducted for PVS in the 3–50 µg·mL −1 range with an R 2 coefficient of determination of 0.9997. PVS had detection and quantification limits of 1.1 and 3.5 µg·mL −1 , respectively, indicating a highly significant correlation between the variables studied. PVS’s recovery percentage was determined to be 101.30%. We also used the Six Sigma lean technique to ensure precision and productivity. PVS was tested for acid, base, oxidative hydrolysis, photodegradation, and heat, as per International Council for Harmonisation guidelines. The highest degradation was obtained from oxidative hydrolysis and thermal degradation.
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DOI: 10.1515/revac-2023-0073
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