Optimized HPLC and UHPLC column classification system used in the pharmaceutical analysis — ASN Events

Optimized HPLC and UHPLC column classification system used in the pharmaceutical analysis (#33)

Tomasz Bączek 1 , Jarosław Szulfer 2 , Alina Plenis 1
  1. Department of Pharmaceutical Chemistry, Medical University of Gdańsk, Gdańsk, Poland
  2. Polpharma SA Pharmaceutical Works, Starogard Gdański, Poland

Pharmacopoeial monographs define usually requirements for the use of the particular chromatographic packing in a very general way. Even if a selection of particular chromatographic column is suggested, it appears often that the column is currently not present in the laboratory, or is no longer commercially available. With respect to those facts, there are needs to replace the given column for another one, however with the similar physicochemical characteristics. This can be achieved by using one of the classification systems of columns (e.g., the procedure developed by the researchers at the Katholieke Universiteit Leuven – and therefore called tentatively by us as KUL procedure).

In the first stage of the work, it has been proven that the results obtained by KUL procedure can be related to results obtained during chemometrics verification of the suitability of selected columns for purity test of three pharmaceutical substances their impurities and related compounds: lamotrigine, caffeine and alfuzosin. The next step was to adapt KUL procedure to allow the classification of modern UHPLC and Core-Shell (CS) columns. Together, properties of 63 columns have been characterized. The last step comprised the data collection to examine the possibility to use UHPLC and CS columns as equivalent ones to the classical HPLC columns in view of the method transfer for the previously mentioned assays of three pharmaceutical substances.

  1. J. Szulfer, A. Plenis, T. Bączek, Evaluation of a column classification method using the separation of alfuzosin from its related substances, J. Chromatogr. A, 1229 (2012) 198-207.
  2. J. Szulfer, A. Plenis, T. Bączek, Application of a column classification method in a selectivity study involving caffeine and its related impurities, Talanta, 99 (2012) 492-501.
  3. J. Szulfer, A. Plenis, T. Bączek, Chemometric evaluation of the column classification system during the pharmaceutical analysis of lamotrigine and its related substances, Anal. Bioanal. Chem., in press.