title: Stability-indicating HPLC assays for the determination of prilocaine and procaine drug combinations.
abstract: Stability-indicating, reversed phase high-performance liquid chromatographic (HPLC) methods have been developed for the determination of several procaine hydrochloride and prilocaine hydrochloride combinations. The separation and quantitation of epinephrine-prilocaine and epinephrine-procaine drug combinations were achieved on a phenyl column using a mobile phase of 80:20% v/v 25 mM phosphate buffer (pH 3.0) containing 50 mM heptanesulfonic acid sodium salt-acetonitrile at a flow rate of 1 ml x min(-1) and UV detection at 254 nm. The method showed linearity for the epinephrine and prilocaine hydrochloride mixture in the 0.25-2.5 and 8-200 micro g ml(-1) ranges, respectively. The intra- and inter-day relative standard deviations (RSDs) ranged from 0.26 to 2.05% and 0.04 to 0.61% for epinephrine and prilocaine hydrochloride, respectively. The epinephrine and procaine hydrochloride mixture yielded linear ranges of 0.25-2.0 and 5-100 micro g ml(-1) and intra- and inter-day RSDs ranged from 0.23 to 1.88% and 0.07 to 0.26% for epinephrine and procaine hydrochloride, respectively. The assays were shown to be suitable for measuring epinephrine-prilocaine and epinephrine-procaine combinations in their respective injection dosage forms. Stability-indicating HPLC assays were also developed for several other procaine drug combinations since their monographs are present in the USP 24; however, quantitation was not investigated since these combinations are not commercially available. A mobile phase consisting of 80:20% v/v 25 mM phosphate buffer (pH 3.0) containing 50 mM heptanesulfonic acid-acetonitrile was utilized for the levonordefrin-tetracaine-procaine drug combination, while a mobile phase consisting of 70:30% v/v 25 mM phosphate buffer (pH 3.0) containing 50 mM heptanesulfonic acid sodium salt-acetonitrile was utilized for the separation of levonordefrin-procaine-propoxycaine and norepinephrine-procaine-propoxycaine. All separations were achieved on a phenyl column at a flow rate of 1 ml x min(-1) and UV detection at 254 nm.
authors.affiliation: Department of Pharmaceutical and Biomedical Sciences, College of Pharmacy, University of Georgia, Athens, GA 30602-2352, USA.
authors.forename: Meredith L
authors.initials: ML
authors.lastname: Storms
authors.forename: James T
authors.initials: JT
authors.lastname: Stewart
mesh_terms: D000779:Anesthetics, Local / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D004338:Drug Combinations; D004355:Drug Stability; D007202:Indicators and Reagents; D009638:Norepinephrine / Q000032:analysis; D019999:Pharmaceutical Solutions; D011318:Prilocaine / Q000032:analysis*; D011343:Procaine / Q000032:analysis*; D012015:Reference Standards; D013056:Spectrophotometry, Ultraviolet
chemical_list: D000779:Anesthetics, Local; D004338:Drug Combinations; D007202:Indicators and Reagents; D019999:Pharmaceutical Solutions; D011318:Prilocaine; D011343:Procaine; D009638:Norepinephrine