Development and validation of a capillary electrophoresis method with ultraviolet detection for the determination of the related substances in a pharmaceutical compound

Identification and quantitation of cis-ketoconazole impurity by capillary zone electrophoresis–mass spectrometry

“…These thresholds have recently been revised (February 2002 and establishing 0.05-0.1% in new drug substances and 0.1-1.0% in new drug products, depending on the amount of drug substance administered per day [1][2][3]. In fact, an accurate analytical profile of a drug substance must fulfill the requirements of regulatory agencies with respect to toxicity and safety aspects from the initial stage of the development of a potential drug to the quality control of a marketed pharmaceutical product [4].…”

Capillary electrophoresis for the analysis of small‐molecule pharmaceuticals

“…A high pH CE method was successfully developed to quantitatively profile the chloromethylated, monomethylated and hydroxylated impurities of a new substance (LAS 35917) [163]. These impurities co-eluted when analysed by HPLC; the CE method allowed detection and quantitation of impurities present at levels of 0.04-0.08% of the parent drug.…”

Zoledronate and Related Impurities Analysis by Capillary Zone Electrophoresis

“…CE is a powerful technique used for the separation of both charged and neutral compounds [9][10][11]. The wide application range includes assay of drugs [12,13], determination of drugs-related impurities [14][15][16][17], analysis of vitamins [18][19][20][21] proteins [22,23] and pharmaceutical excipients [24]. In this context, validated CE techniques with indirect-UV detection, low migration times and, capable to analyze bisphosphonates and related impurities possesses several advantages [25,26].…”