Abstract
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 remedies and 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 60 mM 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% c) was RSD% 2 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.
Highlights
Several analytical methods, employing different techniques, are being developed for separation of studied analytes
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 remedies and preservatives
To our knowledge no publications are present in the literature regarding the simultaneous determination of eleven nitrogenous active compounds and five parabens including p-HydroxyBenzoic Acid (p-HBA) by using The goal of the present study is to develop, optimize and validate a CZE-based analytical method for the simultaneous separation and determination of most commonly-used antihistamines, decongestants and long-acting anticholinergic drugs such as: ChlorPheniramine Maleate (CPM), DiPhenhydramine Hydrochloride (DPH), E, II, Pheniramine Maleate (PM), L, T, Clopamide Hydrochloride (CH), DHE, PhenylEphrine hydrochloride (PE), A and preservatives like as MeP, EP, PP, BP, p-HBA
Summary
Several analytical methods, employing different techniques, are being developed for separation of studied analytes. An accurate and rapid method based on CZE in TBS (pH = 8.5) for the determination of codeine, DPH, E and noscapine in a syrup formulation was described [9]. This method after validation was proposed as a routine one in Quality Control of pharmaceutical preparations. Another paper reported the CZE separation in non-aqueous media: a good resolution for 12 drugs analysis was obtained [16]. Another CZE method was proposed for simultaneous separation of five active compounds (CPM, PE, DPH, E and II). The study regards the influence of capillary dimensions on the sensitivity and efficiency of a validated method [18]
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