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.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callMore From: Journal of Liquid Chromatography & Related Technologies
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
