INTER-COMPANY CROSS-VALIDATION EXERCISE ON CAPILLARY ELECTROPHORESIS .1. CHIRAL ANALYSIS OF CLENBUTEROL

In order to assess the repeatability of capillary electrophoresis (CE) and to demonstrate the successful transfer of CE methods between independent laboratories a working party comprising seven pharmaceutical companies was established. Three cross-validation exercises are scheduled. The first is the chiral analysis of clenbuterol. This paper gives the results from this initial study. The method was successfully transferred between all the participating companies. In each case baseline separation or better of the enantiomers was obtained. Good performance in terms of precision for both peak area and migration time, linearity and accuracy was obtained. This exercise clearly demonstrates that the CE method investigated is capable of generating accurate and precise data.