A RP-LC method with evaporative light scattering detection for the assay of simethicone in pharmaceutical formulations.
A reversed-phase liquid chromatographic method has been developed and validated for the determination of the polydimethylsiloxane (PDMS) component of Simethicone, which is used as an anti-foaming agent in pharmaceutical formulations. The method involves acidification to neutralise antacid components of the formulation, then a single extraction of the PDMS with dichloromethane. This is followed by separation with a reversed-phase column using an acetonitrile-chloroform solvent gradient, and quantification by an evaporative light scattering detector. An assay precision of 3% was achieved in intraday and interday determinations. No interference was found from the aluminium and magnesium hydroxide components of antacid formulations.
Moore
Douglas E
DE
Faculty of Pharmacy, The University of Sydney, Sydney 2006, Australia. demoore@pharm.usyd.edu.au
Liu
Tina X
TX
Miao
William G
WG
Edwards
Alison
A
Elliss
Russell
R
D000536:Aluminum Hydroxide / Q000032:analysis; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004338:Drug Combinations; D008027:Light; D008276:Magnesium Hydroxide / Q000032:analysis; D004364:Pharmaceutical Preparations / Q000032:analysis; D012542:Scattering, Radiation; D012841:Simethicone / Q000032:analysis*
D004338:Drug Combinations; D004364:Pharmaceutical Preparations; C008570:aluminum hydroxide, magnesium hydroxide, simethicone drug combination; D000536:Aluminum Hydroxide; D012841:Simethicone; D008276:Magnesium Hydroxide