Abstract
The development and validation of a reversed-phase high performance liquid chromatographic (RP-HPLC) method with ultra-violet (UV) detection for the quantification and purity determination of aplidine in raw drug substance and pharmaceutical dosage form is described. Using this method, the aplidine rotamers present as a consequence of cis-trans isomerism of the peptide bond between the proline and pyruvoyl moieties in the molecule, elute as one single peak. Linear calibration curves in the range of 12.5–300 μg/mL of aplidine with correlation coefficients > 0.999 were obtained. Within-run and between-run precisions were ≤ 2.2% and accuracy was within 100.6–101.4%. A profile of recurrent impurities was drawn up from several lots of aplidine raw drug substance manufactured thus far. Major impurities were identified as didemnin-A, acetyldidemnin A, and noraplidine using liquid chromatography-mass spectrometry (LC-MS). No significant differences in chromatographic profile between aplidine raw drug substance and its pharmaceutical dosage form were found.
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More From: Journal of Liquid Chromatography & Related Technologies
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