Nilusha Padivitage, Lin Wang, Rasangi M Wimalasinghe
Aug 22, 2021
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Journal
Chromatographia
Abstract
Eprinomectin (EPM) is the active pharmaceutical ingredient (API) of the pour-on finished product. The finished product also contains propylene glycol octanoate decanoate (PGOD) as an excipient and solvent, and butylated hydroxytoluene (BHT) as an antioxidant. EPM belongs to a group of compounds known as avermectins and is commercially available as a mixture of two closely related homologues, namely, EPM B1a and EPM B1b. A stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method is developed and validated, which can provide data for EPM assay and estimation of its degradation products as well as the assay of BHT from the chromatogram of a single injection of the finished product sample. The new HPLC method uses a Halo-C18 column (100 mm × 4.6 mm i.d., 2.7 µm particle size) maintained at 40 °C with 100% Water (H2O) as Mobile Phase-A and Isopropanol(IPA)/Acetonitrile(ACN) (70/30, v/v) as Mobile Phase-B. Analytes are separated by a gradient elution with a total run time of 35 min. EPM and its degradation products except 8a-oxo-B1a are detected by UV at 245 nm while 8a-oxo-B1a and BHT are detected at 280 nm.