JOURNAL ARTICLE

Development and Validation of a Single Stability-Indicating Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC) Method for Identification and Assay of Eprinomectin in Two Different Commercial Injectable Drug Products for Cattle.

  • Published In: Journal of AOAC International, 2025, v. 108, n. 3. P. 304 1 of 3

  • Database: Academic Search Ultimate 2 of 3

  • Authored By: Dharmaratne, Nayanthara U; Rustum, Abu M 3 of 3

Abstract

This article focuses on the development and validation of a single, stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for the identification and assay of eprinomectin (EPRN) in two injectable veterinary drug products used to treat internal parasites in cattle. The method employs a Halo-C18 column with 0.1% aqueous perchloric acid and ethanol as mobile phases, achieving separation of EPRN's main components (B1a and B1b) and the critical impurity 26-epimer B1a within 20 minutes. Validated according to International Conference on Harmonization (ICH) guidelines, the method demonstrated robustness, linearity, accuracy, precision, specificity, and stability-indicating capability, and an equivalent Ascentis Express C18 column was also validated. This RP-HPLC method addresses the lack of existing pharmacopeial assays for EPRN in finished products and supports reliable routine and non-routine quality control analysis of multi-component veterinary formulations.

Additional Information

  • Source:Journal of AOAC International. 2025/05, Vol. 108, Issue 3, p304
  • Document Type:Article
  • Subject Area:Chemistry
  • Publication Date:2025
  • ISSN:1060-3271
  • DOI:10.1093/jaoacint/qsaf006
  • Accession Number:184925711
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