Stability of non-aqueous topical tetracaine and clotrimazole solutions in polypropylene droptainer bottles

Tetracaine topical solution may improve patient adherence with topical clotrimazole therapy for fungal otitis externa. The chemical stability of tetracaine 1% and combination clotrimazole 1% with tetracaine 1% topical solutions was determined using a stability-indicating high-performance liquid chro...

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Bibliographic Details
Published inInternational journal of pharmaceutical compounding Vol. 17; no. 6; p. 508
Main Authors McPherson, Timothy B, Neumann, William L, Kolling, William M
Format Journal Article
LanguageEnglish
Published United States 01.11.2013
Subjects
Chromatography, High Pressure Liquid
Clotrimazole - analysis
Clotrimazole - chemistry
Drug Packaging
Drug Stability
Polypropylenes
Solutions
Tetracaine - analysis
Tetracaine - chemistry
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Summary:Tetracaine topical solution may improve patient adherence with topical clotrimazole therapy for fungal otitis externa. The chemical stability of tetracaine 1% and combination clotrimazole 1% with tetracaine 1% topical solutions was determined using a stability-indicating high-performance liquid chromatography assay. Propylene glycol and polyethylene glycol 400 were used as anhydrous solvents. Standard curves for tetracaine and clotrimazole were linear with r2 > or = 0.999. Clotrimazole did not degrade in either propylene glycol or polyethylene glycol 400 throughout the 90-day study period. Tetracaine degraded significantly in propylene glycol but not in polyethylene glycol 400. A beyond-use date of 90 days is supported for tetracaine and the combination clotrimazole-tetracaine solution in polyethylene glycol 400. A beyond-use date of 60 days is supported for tetracaine and the combination clotrimazole-tetracaine in propylene glycol.
ISSN:1092-4221