Development and validation of HPLC-UV method for the quantitative analysis of carcinogenic organic impurities and its isomers in the sodium polystyrene sulfonate polymer

Sodium polystyrene sulfonate (SPS) powder is in use for over 50 years for the treatment of hyperkalemia. SPS powder is official in United States Pharmacopoeia, British Pharmacopoeia and European Pharmacopoeia. However, till date, no study has been published on the assessment of organic impurities fo...

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Veröffentlicht in:	Acta chromatographica 2021-06, Vol.33 (2), p.162-169
Hauptverfasser:	Zinjad, Pushpavati, Gondhale, Priyanka, Kulkarni, Shrikant, Musmade, Bhaskar, Bhope, Shrinivas, Padmanabhan, Sriram
Format:	Artikel
Sprache:	eng
Schlagworte:	Benzene Carcinogens Divinylbenzene High-performance liquid chromatography Hydrocarbons Hyperkalemia Impurities Isomers Liquid chromatography Naphthalene Oxidative stress Pharmacology Polymers Polystyrene Polystyrene resins Powder Product safety Quantitation Quantitative analysis Robustness (mathematics) Ruggedness Sodium Sodium polystyrene sulfonate Sodium salts Stability Styrene Sulfonates Thermal stress
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