Stability of Non-aqueous Topical Tetracaine and Clotrimazole Solutions in Polypropylene Droptainer Bottles

McPherson, Timothy B; Neumann, William L; Kolling, William M

Abstract

Stability of Non-aqueous Topical Tetracaine and Clotrimazole Solutions in Polypropylene Droptainer Bottles

Author(s): McPherson Timothy B, Neumann William L, Kolling William M

Issue: Nov/Dec 2013 - Volume 17, Number 6

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Page(s): 508-511

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Abstract

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 = 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.

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