The paper deals with the development of a rapid and
efficient Capillary Zone Electrophoresis (CZE) method for Quality Control
analysis of pharmaceutical preparations containing antihistamines,
decongestants, anticholinergic remediesand preservatives. Active ingredients of interest are: ChlorPheniramine
Maleate (CPM), DiPhenhydramine Hydrochloride (DPH), Ephedrine hydrochloride
(E), Isopropamide Iodide (II), Pheniramine Maleate (PM), Lidocaine hydrochloride
(L), Tetracaine hydrochloride (T), Clopamide Hydrochloride (CH),
DiHydroErgochristine (DHE), PhenylEphrine hydrochloride (PE) and Acetaminophen
(A). Preservatives studied are: MethylParaben (MeP),
EthylParaben (EtP), PropylParaben (PrP), ButylParaben (BuP), p-HydroxyBenzoic Acid (p-HBA). All these analytes were separated in a single run
using 60mM tetraborate
buffer solution (TBS) pH=9.2 as a
BackGround Electrolyte (BGE) by using an uncoated fused silica capillary of
I.D. = 50 mm and applying a voltage of 25 kV in
the first part of the electropheretic run (up to 5.8 min) and 30 kV for the
remaining time. The hydrodynamic pressurization of the inlet vial was 20 psi at
7.2 min. up to the end of analysis. Total separation time was of 7.5 min. The
method was then successfully validated and applied to the simultaneous
determination of active ingredients and preservatives. Good repeatability,
linearity, and sensitivity were demonstrated. Precision
of migration time (tm) was RSD%< 0.53% and of
corrected peak area (Ac) was RSD%< 6.15%. The
linearity evaluation gave 0.9928 < r2 <1.000.
LOD and LOQ, accuracy (recovery) and ruggedness were evaluated for each analyte
demonstrating the good reliability of the method. Analyses of some
pharmaceutical real samples were performed.
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