Use of a Single Capillary Electrophoresis Method as a Routine Identity Test for Batch Release of a Range of Pharmaceutical Products

Abstract

Two independent and orthogonal analytical methods are required when performing identity testing of pharmaceutical products during routine release testing. A microemulsion electrokinetic chromatography method has been developed and validated for routine use as an identity test to release various pharmaceutical products including tablets, capsules and creams. Implementation of the method involved optimisation of parameters to achieve reliable routine operation. Rinsing procedures, in particular, were found to be essential to obtain consistent profiles and migration times. The method has replaced, and offers the potential to replace, a number of methods including HPLC and IR due to the considerable cost and time savings obtained through its use. This method has been successfully approved by the US FDA as a part of 2 New Drug Applications, is registered in Japan, and is in routine QA use within a factory environment.

Recent advances in capillary electrophoretic migration techniques for pharmaceutical analysis (2013–2015)

“…CE is an important technique for analyzing many pharmaceutical and biopharmaceutical substances . Consequently, protocols for method validation and instrument qualification have been developed and CE methods have been applied during all stages of drug discovery as well as quality control of the finished products .…”

“…In pharmaceutical analysis, CE has been applied to the determination of the main component as well as the purity of drugs with regard to related substances and stereoisomeric impurities, of drug counter‐ions, of physicochemical properties such as log P and pK a . Drug‐macromolecule binding properties were studied by ACE .…”

Recent advances in capillary electrophoretic migration techniques for pharmaceutical analysis

“…In the case of small‐molecule pharmaceuticals, CE has been employed for the determination of drug identity and purity with regard to related substances and stereoisomeric impurities, of drug counterions, of physicochemical properties such as log P and p K a , or of drug–macromolecule binding constants . With regard to the CE analysis of biopharmaceuticals, the so‐called CE‐SDS, which refers to capillary gel electrophoresis replacing the classical SDS‐PAGE, and CIEF have been implemented for protein characterization .…”

“…While CE and HPLC have been considered competitors in the early days of CE, it is now acknowledged that they are complementary techniques based on the different separation mechanisms, each with its advantages and disadvantages with regard to a given set of analytes. Taking into account the above‐cited literature , it can be concluded that CE has advanced to a mature technique for all aspects of pharmaceutical analysis. The present review focuses on recent advances and applications of capillary electromigration techniques for the analysis of pharmaceutical substances covering many recent literatures until mid‐2013.…”

“…These analyses have been summarized elsewhere, for example, in and are not included in the present review either. For earlier compilations of the use of capillary electromigration methods in drug analysis see, for example, .…”