Development and Validation of a Stability-Indicating RP-HPLC Method for Determination of Eprinomectin, its Degradation Products, and Butylated Hydroxytoluene in a Pour-On Finished Product

The topical product with three active pharmaceutical ingredients (APIs), namely, esafoxolaner, eprinomectin and praziquantel has demonstrated its efficacy in the treatment of cats with mixed infections with ectoparasites and nematodes and cestodes. A reversed-phase high-performance liquid chromatography (RP-HPLC) method has been developed and validated for assay and determination of related substances peaks of three APIs including the assay of antioxidant butylated hydroxytoluene (BHT) in the finished product. Analytes were separated on a short Zorbax SB-C18 column (50 × 4.6 mm I.D., 5 μm particle size, pore size: 80 Å) with gradient elution at 40 °C column temperature. Analytes were detected at 245 nm for praziquantel, esafoxolaner, eprinomectin and their degradation products. BHT and eprinomectin degradation product 8a-oxo-B1a were detected at 280 nm. All analytes of interest were adequately separated within 40 min. The assay for praziquantel, esafoxolaner, eprinomectin and BHT was conducted against their corresponding external reference standards. The related substances peaks of each API were determined by peak area and relative response factor against total peak area of their corresponding API peak in sample solution. This method has been demonstrated to be accurate, robust, specific and stability indicating.

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Development and Validation of a Stability-Indicating RP-HPLC Method for Determination of Eprinomectin, its Degradation Products, and Butylated Hydroxytoluene in a Pour-On Finished Product

Cited by 3 publications

References 25 publications

Estimating Butylated Hydroxytoluene in the Presence of Polymers such as Polyethylene Glycol and Polyethylene Oxide in Mirabegron Extended-Release Tablets

Estimating Butylated Hydroxytoluene in the Presence of Polymers such as Polyethylene Glycol and Polyethylene Oxide in Mirabegron Extended-Release Tablets

Simultaneous determination of praziquantel, fipronil, eprinomectin, (S)-methoprene, their key related substances and butylated hydroxytoluene (BHT) in a topical veterinary drug product by a single stability indicating high performance liquid chromatography method

Simultaneous Determination of Esafoxolaner, Eprinomectin, Praziquantel, BHT and Their Related Substances in a Topical Finished Product by a Single Reversed-Phase High-Performance Liquid Chromatography Method

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