title: Stability of acetylcysteine in an extemporaneously compounded ophthalmic solution.
abstract: The stability of acetylcysteine in an extemporaneously compounded ophthalmic solution was studied. Acetylcysteine 10% ophthalmic solution containing 0.025% disodium edetate and 0.5% chlorobutanol in an artificial tears base was prepared and stored at 2-8 degrees C in clear, 15-mL, low-density polyethylene dropper bottles. At 0, 7, 14, 21, 28, 35, and 60 days, a 1-mL sample was removed from each bottle and analyzed for acetylcysteine concentration by high-performance liquid chromatography. Another set of 10% acetylcysteine solutions containing 0.025%, 0.050%, 0.075%, or 0.10% disodium edetate were prepared, stored at room temperature (23-25 degrees C), and analyzed at 0, 7, 15, 30, 40, and 50 days. In the solutions containing 0.025% disodium edetate, acetylcysteine was stable for 60 days at 2-8 degrees C but for less than 7 days at 23-25 degrees C. In the solutions containing 0.75% and 0.10% disodium edetate, acetylcysteine was stable for 40 and 50 days, respectively, at 23-25 degrees C. Acetylcysteine in a 10% acetylcysteine ophthalmic solution containing 0.025% disodium edetate and 0.5% chlorobutanol in an artificial tears base was stable for 60 days at 2-8 degrees C.
authors.affiliation: Department of Pharmacy, University of Rochester (UR), NY, USA. nanaizi@pharmacy.urmc.rochester.edu
authors.forename: N H
authors.initials: NH
authors.lastname: Anaizi
authors.forename: C F
authors.initials: CF
authors.lastname: Swenson
authors.forename: P J
authors.initials: PJ
authors.lastname: Dentinger
mesh_terms: D000111:Acetylcysteine / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D006801:Humans; D006863:Hydrogen-Ion Concentration / Q000187:drug effects; D009093:Mucus / Q000187:drug effects; D009883:Ophthalmic Solutions / Q000737:chemistry*; D013696:Temperature
chemical_list: D009883:Ophthalmic Solutions; D000111:Acetylcysteine