Multivariate Optimization and Validation of a CZE Method for the Analysis of Pridinol Mesylate and Meloxicam in Tablets

VIGNADUZZO, S. E.; VERA CANDIOTTI, L.; CASTELLANO, P. M.; GOICOECHEA. H. C.; KAUFMAN, T. S.

CHROMATOGRAPHIA

VIEWEG

Lugar: Heidelberg; Año: 2011 vol. 74 p. 609 - 617

0009-5893

A capillary zone electrophoresis method for the simultaneous determination of pridinol mesylate (PRI) and meloxicam (MEL) employing epinastine hydrochloride and piroxicam as internal standards, was developed and opti mized employing experimental design and response sur- face methodologies. The separation was optimally achieved in less than 2 min at 30 kV in an uncoated fused- silica capillary (41.4 cm 9 75 lm I.D.), employing an 18 mmol L-1 sodium phosphate buffer solution (pH 5.90) at 25 _C. Samples were injected in hydrodynamic mode (50 mbar, 5 s) and the analytes were spectrophotometri cally detected at 200 nm. Method robustness was demon-strated by ANOVA of determinations performed underconditions slightly different from the optimum. The method was validated regarding separation selectivity (peak purity factors[0.99), linearity and range (PRI = 17.6–31.4 mg L-1; MEL = 66.5–122.5 mg L-1), accuracy (PRI = 100.2–101.9%; MEL = 98.9–100.7%) and precision. The RSD values obtained were B1.3% for injection repeatability and B1.9% for intra-day precision. The limits of detection (1.0 and 0.9 mg L-1) and quanti fication (3.3 and 16.5 mg L-1) of PRI and MEL, respectively, were also determined. The method was suc cessfully applied to the determination of both drugs in three brands of tablet formulations. No statistically significant differences were observed when these results were com- pared with those of a RP-HPLC method.