Determination of topiramate and its degradation product in liquid oral solutions by high performance liquid chromatography with a chemiluminescent nitrogen detector.
Topiramate is a sulfamate-substituted monosaccharide that is prescribed for the treatment of epilepsy. It has been a challenge to develop analytical methods for topiramate formulations because the compounds of interest do not have chromophores that are active above 190 nm and because of interference from excipients. This paper describes a simple, specific, precise, accurate, and sensitive method using a chemiluminescent nitrogen detector. The method has a validated linearity range of 32-4800 ng of topiramate and excellent precision (system repeatability). The limit of quantitation was determined to be 0.1% for the degradation product w/w versus topiramate. The method has been successfully used for probe stability studies in support of early phase formulation development.
Styslo-Zalasik
Maria
M
Global Analytical Development, Johnson & Johnson Pharmaceutical Research & Development, LLC, 1000 Route 202, Raritan, NJ 08869, USA. mstysloz@prdus.jnj.com
Li
Weiyong
W
D000284:Administration, Oral; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D005632:Fructose / Q000031:analogs & derivatives* / Q000032:analysis* / Q000737:chemistry / Q000378:metabolism*; D008163:Luminescent Measurements / Q000295:instrumentation / Q000379:methods*; D009584:Nitrogen / Q000032:analysis*; D019999:Pharmaceutical Solutions / Q000032:analysis* / Q000737:chemistry / Q000378:metabolism; D012996:Solutions; D000077236:Topiramate
D019999:Pharmaceutical Solutions; D012996:Solutions; D000077236:Topiramate; D005632:Fructose; D009584:Nitrogen