Abstract
In this study, two novel resonance light scattering (RLS) methods were developed for the determination of benzalkonium chloride. These methods were based on the formation of inorganic anionic-surfactant aggregates in a Clark-Lubs medium, which increases the resonance light scattering intensity of the reaction system and were also predominantly divided into sodium tungstate-benzalkonium chloride (method A) or phosphomolybdate-benzalkonium chloride (method B). The detection is performed both at 285 nm. Under the established conditions, the limits of quantification ranged from 0.10 mg L–1 to 1.00 mg L–1 with the R values of 0.9994 and from 0.20 mg · L–1 to 3.20 mg · L–1 with the R values of 0.9991, with good precision and accuracy both for method A and method B. The limits of detection were 0.029 mg · L–1 for method A and 0.013 mg · L–1 for method B. These two methods were successfully applied for the assay of benzalkonium chloride for the first time. All validation parameters were in agreement with the International Conference on Harmonization of Requirements for Registration Pharmaceuticals for Human Use (ICH) guidelines. Compared to the classical spectrophotometric method, these two methods take advantages of rapidity, high efficiency and good selectivity.
Abstract
In dieser Studie wurden zwei neuartige Resonanz-Lichtstreumethoden (RLS) zur Bestimmung von Benzalkoniumchlorid entwickelt. Die Methoden basierten auf der Bildung anorganischer anionischer Tensidaggregate in einem Clark-Lubs-Medium, was die Resonanzlichtstreuungsintensität des Reaktionssystems erhöht, und wurden in die Natriumwolframat-Benzalkoniumchlorid-Methode (A) oder die Phosphomolybdat-Benzalkoniumchlorid-Methode (B) unterteilt. Der Nachweis erfolgt jeweils bei 285 nm. Unter den festgelegten Bedingungen reichten die Bestimmungsgrenzen von 0,10 mg L–1 bis 1,00 mg L–1 mit R-Werten von 0,9994 und von 0,20 mg L–1 bis 3,20 mg L–1 mit R-Werten von 0,9991, mit guter Präzision und Genauigkeit sowohl für Methode A als auch für Methode B. Die Nachweisgrenzen lagen bei 0,029 mg L–1 für Methode A und bei 0,013 mg L–1 für Methode B. Diese beiden Methoden wurden zum ersten Mal erfolgreich für die Bestimmung von Benzalkoniumchlorid eingesetzt. Alle Validierungsparameter stimmten mit den Richtlinien der International Conference on Harmonization of Requirements for Registration Pharmaceuticals for Human Use (ICH) überein. Verglichen mit der klassischen spektrophotometrischen Methode zeichnen sich diese beiden Methoden durch Schnelligkeit, hohe Effizienz und gute Selektivität aus.
About the authors
Yinhua Li, female, the Han nationality, native place: Shandong, China. School of Chemistry Engineering, master’s degree. Tel: 15705145392
Zhongyuan Xu, female, the Han nationality, native place: Heilongjiang, China. College of Marine Life And Fisheries, master’s degree.
Mengting Yu, female, the Han nationality, native place: Jiangsu, China. School of Pharmacy, master’s degree.
Zhen Wang, male, the Han nationality, native place: Jiangsu, China. School of Pharmacy, master’s degree.
Weixing Ma, male, the Han nationality, native place: Jiangsu, China. He is a professor at Jiangsu University Ocean (China). His research interests are pharmaceutical analysis and crystal synthesis. Doctor’s degree.
Zibo Dong, male, the Han nationality, native place: Jiangsu, China. He is a professor at Jiangsu University Ocean (China). His research interests is new medical research. Doctor’s degree.
Acknowledgements
The authors acknowledge Huaihai Institute of Technology Postgraduate Research Innovation Project for supporting by the grant KYCX19-2270 and National Natural Science Foundation of China by the grant 81773968.
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