Anovel economic procedure for stereospecific separation and analysis of (
)-bupivacaine has been developed and validated. Use of different thin-layer chromatographic plates and different cyclodextrins at different temperatures was investigated. The spots were detected with either iodine vapor, or by use of a UV lamp followed by densitometric measurements at 262 nm. A comparative study was performed using different cyclodextrins — hydroxylpropyl-β-cyclodextrin (HP-β-CD), methyl-β-cyclodextrin (M-β-CD), and dimethyl-β-cyclodextrin (DM-β-CD) — as chiral selectors. The mobile phase enabling successful resolution of (
)-bupivacaine was acetonitrile-methanol-water 15:2.5:2.5 (
) containing 1 mM HP-β-CD; analysis was performed at ambient temperature (25 ± 2°C). The effect on resolution of the concentration of different chiral selectors, temperature, and pH was studied. Calibration plots for analysis of the R and S enantiomers were linear in the range 1.25–35.00 μg per spot (
= 6) with acceptable precision (RSD < 2.0%) and accuracy (RE = −1.5–2.8%). The limits of detection and quantification were 0.66 and 2.22 μg per spot, respectively, for (
)-bupivacaine, and 0.88 and 2.94 μg per spot for (
)-bupivacaine. The method is simple, selective, and robust, and can be used for identification and quantification of the enantiomers of bupivacaine in the drug substance and in pharmaceutical dosage forms.
The United Stated Pharmacopoeia “The National Formulary USP
” United States Pharmacopoeial Convection Inc., 2007, 1562.
, Martindale, The Extra Pharmacopoeia,
ed., Pharmaceutical Press, London, 2005, 1371, 1372, 1377.
Sweetman S.C., '', in Martindale, The Extra Pharmacopoeia, (2005) -.
Sweetman S.C.Martindale, The Extra Pharmacopoeia2005)| false