Quantitation of taurolidine decomposition in polymer solutions by chromotropic acid formaldehyde assay method.
A sensitive, selective, and specific assay was needed to study the degradation kinetics of taurolidine and its stabilization by polyvinylpyrrolidone (PVP). The purpose of the present study was to evaluate the usefulness of the chromotropic acid method and other formaldehyde or amine derivatization methods. The methods evaluated included formaldehyde derivatization with chromotropic acid, acetylacetone, 4-amino-5-hydrazino-3-mercapto-1,2,4-triazole, semicarbazide hydrochloride, or 2,4-dinitrophenylhydrazine and taurolidine decomposition product derivatization with dansylchloride or 7-chloro-4-nitrobenz-2-oxa-1,3-diazole chloride. Results indicated that the chromotropic acid method provided sufficient selectivity, reproducibility and sensitivity. It was able to quench taurultam decomposition and avoided PVP interference. The method was optimized by performance based selection of reagent lots, appropriate reagent storage and preparation, and controlled derivatization conditions. In conclusion, the optimized chromotropic method was the most appropriate method for quantitating taurolidine decomposition.
Sihn
Y S
YS
Division of Pharmaceutics, College of Pharmacy, The University of Iowa, Iowa City 52242, USA.
Guillory
J K
JK
Kirsch
L E
LE
D000890:Anti-Infective Agents / Q000032:analysis / Q000737:chemistry*; D002863:Chromogenic Compounds / Q000032:analysis*; D004355:Drug Stability; D005557:Formaldehyde / Q000032:analysis* / Q000737:chemistry; D006863:Hydrogen-Ion Concentration; D009282:Naphthalenesulfonates / Q000032:analysis*; D011205:Povidone; D012996:Solutions; D013053:Spectrophotometry / Q000379:methods; D013654:Taurine / Q000031:analogs & derivatives* / Q000032:analysis / Q000737:chemistry; D013696:Temperature; D013829:Thiadiazines / Q000032:analysis / Q000737:chemistry*
D000890:Anti-Infective Agents; D002863:Chromogenic Compounds; D009282:Naphthalenesulfonates; D012996:Solutions; D013829:Thiadiazines; D013654:Taurine; D005557:Formaldehyde; C012566:taurolidine; D011205:Povidone; C111424:taurultam; C111425:taurineamide; C020996:chromotropic acid