Impurity analysis of pharmaceuticals using capillary electromigration methods

Abstract

This review deals with the determination of impurities in pharmaceuticals by electromigration methods in the capillary format. These separation methods are either based on the different effective mobility of the charged analytes (as in zone electrophoresis and isotachophoresis) or include hybrid methods such as micellar electrokinetic chromatography, microemulsion electrokinetic chromatography and electrochromatography. The pharmaceutically active compounds under consideration belong to chemotherapeutic agents, central nervous system drugs, histamine receptor drugs, cardiovascular drugs, anticancer drugs, anti-inflammatory drugs and some other drugs. The review discusses about 150 publications from the period between 1980 and 2007 with special emphasis on the recent trends and gives details about the experimental conditions applied for analyses and the obtained analytical performance parameters.

Genotoxic Impurities in Pharmaceuticals

“…Finally, it was concluded that the method is suitable for routine quality control and stability analyses, especially in the developing world (Jindal et al 1994). Jouyban and Kenndler (2008) reviewed the applicability of capillary electrophoresis (CE) methods for the analysis of pharmaceutical impurities. In addition, they discussed the applications of these methods in various groups of compounds such as chemotherapeutic agents, central nervous system (CNS) drugs, histamine receptor and cardiovascular drugs.…”

“…Mahuzier et al (2001) demonstrated the poor sensitivity of CE based methods, in comparison to other separation methods. The problem of limited sensitivity of CE methods can be solved either by the use of detection methods with sensitivity higher than UV absorption or by pre-concentration of the analytes (Jouyban and Kenndler, 2008).…”

Chiral electromigration techniques in pharmaceutical and biomedical analysis

“…Further examples can be found in several reviews, for example [5][6][7]79]. The application of CE in drug impurity analysis has been summarized [79,80]. Table 1 clearly reflects the general trend that CDs are by far the most widely used chiral selectors although some studies utilized other additives such as BSA [81], maltodextrin [82], (+)-18C6H4 [83], ligand exchange [84] or the chiral ionic liquid ethylcholine bis(trifluoromethylsulfonyl) Baclofen α-CD (18 mM) 0.1 M sodium borate, pH 9.9, 1% acetonitrile 2-10 μg/ml, analysis of racemic bulk drug and tablets [103] Benzimidazole derivatives Chloroquine SBE-β-CD (30 mg/ml) 100 mM sodium phosphate, pH 2.5 0.02%, analysis of laboratory sample [108] Clopidogrel Sulfated β-CD (5%) 10 mM triethylamine/phosphoric acid 0.08-0.33 μg/ml, minor enantiomer and related substances [109] Dexamphetamine HDAS-β-CD (10 mg/ml) 0.1 M sodium phosphate buffer, pH 2.5 0.06%, minor enantiomer and charged related substances [91] Dexamphetamine Sulfated β-CD (25 mg/ml), SBE-β-CD (80 mg/ml) 50 mM sodium phosphate buffer, pH 2.5 0.01-0.02%, minor enantiomer and related substances [92] Dexamphetamine Sulfated β-CD (5.5%) 1.5% SDS, 0.5% ethyl acetate, 3.5% 1-butanol, 2.5% 2-propanol and 92% 50 mM sodium phosphate buffer, pH 3.0 0.05-0.2%, minor enantiomer and related substances [93] Econazole HP-γ-CD (40 mM) 50 mM SDS in 20 mM phosphate buffer, pH 8.0…”

Separation and Quantification of 1,4-benzodiazepines: HPLC versus CZE

“…While HPLC remains the most common technique for the analysis of benzodiazepines, 7,9,14,15 mainly in reversed phase (RP) mode, several capillary zone electrophoresis (CZE) methods have recently been developed. 2,16,17 CZE represents an interesting alternative to HPLC for determination of pharmaceuticals, in general, 18,19 mainly because of its higher efficiency in comparison with HPLC. 20 The aim of this work was to develop and optimize separation conditions for a set of seven 1,4-BZDs in RP-HPLC and CZE with UV detection and compare these methods in terms of efficiency, analysis time, resolution, elution order and basic validation parameters.…”