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Stability-indicating HPLC assays for the determination of prilocaine and procaine drug combinations
- Source :
- Journal of Pharmaceutical and Biomedical Analysis. 30:49-58
- Publication Year :
- 2002
- Publisher :
- Elsevier BV, 2002.
-
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.
- Subjects :
- Sodium
Clinical Biochemistry
Pharmaceutical Science
chemistry.chemical_element
Procaine Hydrochloride
High-performance liquid chromatography
Prilocaine
Dosage form
Analytical Chemistry
Norepinephrine
Procaine
Drug Stability
Drug Discovery
medicine
Anesthetics, Local
Chromatography, High Pressure Liquid
Spectroscopy
Prilocaine Hydrochloride
Chromatography
Chemistry
Reference Standards
Drug Combinations
Pharmaceutical Solutions
Indicators and Reagents
Spectrophotometry, Ultraviolet
Quantitative analysis (chemistry)
medicine.drug
Subjects
Details
- ISSN :
- 07317085
- Volume :
- 30
- Database :
- OpenAIRE
- Journal :
- Journal of Pharmaceutical and Biomedical Analysis
- Accession number :
- edsair.doi.dedup.....c5cbc85f59ced15dc7f4f2283f6fd091