PMID- 12151064 OWN - NLM STAT- MEDLINE DCOM- 20021125 LR - 20220409 IS - 0731-7085 (Print) IS - 0731-7085 (Linking) VI - 30 IP - 1 DP - 2002 Aug 22 TI - Stability-indicating HPLC assays for the determination of prilocaine and procaine drug combinations. PG - 49-58 AB - 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. FAU - Storms, Meredith L AU - Storms ML AD - Department of Pharmaceutical and Biomedical Sciences, College of Pharmacy, University of Georgia, Athens, GA 30602-2352, USA. FAU - Stewart, James T AU - Stewart JT LA - eng PT - Journal Article PL - England TA - J Pharm Biomed Anal JT - Journal of pharmaceutical and biomedical analysis JID - 8309336 RN - 0 (Anesthetics, Local) RN - 0 (Drug Combinations) RN - 0 (Indicators and Reagents) RN - 0 (Pharmaceutical Solutions) RN - 046O35D44R (Prilocaine) RN - 4Z8Y51M438 (Procaine) RN - X4W3ENH1CV (Norepinephrine) SB - IM MH - Anesthetics, Local/*analysis MH - Chromatography, High Pressure Liquid MH - Drug Combinations MH - Drug Stability MH - Indicators and Reagents MH - Norepinephrine/analysis MH - Pharmaceutical Solutions MH - Prilocaine/*analysis MH - Procaine/*analysis MH - Reference Standards MH - Spectrophotometry, Ultraviolet EDAT- 2002/08/02 10:00 MHDA- 2002/11/26 04:00 CRDT- 2002/08/02 10:00 PHST- 2002/08/02 10:00 [pubmed] PHST- 2002/11/26 04:00 [medline] PHST- 2002/08/02 10:00 [entrez] AID - S0731708502001954 [pii] AID - 10.1016/s0731-7085(02)00195-4 [doi] PST - ppublish SO - J Pharm Biomed Anal. 2002 Aug 22;30(1):49-58. doi: 10.1016/s0731-7085(02)00195-4.