Development of a Reversed-Phase HPLC Method by Applying a Scientific Approach and Strategies to Achieve Challenging Separation of Impurity Peaks in Typical Commercial Bulk Batches of Milbemycin Oxime Drug Substance
An exhaustive equivalency study between the new HPLC method and the compendial methods demonstrated that the new method is superior compared to the European Pharmacopoeia (Ph. Eur.) method for analyzing MO bulk drug substance.
Authors
- Sarju Adhikari (ORCID: https://orcid.org/0000-0002-2107-0396)
- Renuka Rathnasekara (ORCID: https://orcid.org/0009-0000-7209-0568)
- Abu M. Rustum (ORCID: https://orcid.org/0000-0003-0764-2738)
- Milan Dissanayake (ORCID: https://orcid.org/0000-0001-9926-4599)
Institutions
- Boehringer Ingelheim (United States) (US)
Publication Details
- Journal
- Journal of AOAC International
- Published
- 2025-04-12
- DOI
- https://doi.org/10.1093/jaoacint/qsaf034
- Citations
- 1
- Primary Topic
- Synthesis and Biological Evaluation
- Type
- article
- Field-Weighted Citation Impact
- 0.94