Impurity profiling of l-methionine by HPLC on a mixed mode columnRaphael Kühnreich, Ulrike Holzgrabe∗
tMethionine is mostly produced synthetically. Thus, impurities are synthesis by-products in addition tooxidation and dimerization products. Here, a sensitive HPLC method for the determination of impu-rities in l-methionine was developed and validated using a SIELC®rimesep 100 column. Impuritieswere separated on the mixed mode column by reversed phase and cationic exchange mechanism.The limit of detection was in the range of 0.06–0.30 g/ml (0.0004–0.002%), limit of quantification inthe range of 0.30–0.75 g/ml (0.002–0.005%) and linearity was shown in the range of 0.3–30.0 g/ml(0.002–0.200%). The method was found to be precise (intermediate precision RS <5%; n = 2) and accurate(recovery 96.0–121.4%, n = 3). The method is also suitable for the purity assessment of dl-methionine andd-methionine. The amount of impurities found in batches was very low. Only l-methionine-sulfoxide andN-acetyl-dl-methionine could be detected in levels less than 0.05%