Ivermectin injectable product is widely used as a parasiticide for the treatment and control of internal and external parasites of cattle and swine. A reversed-phase high performance liquid chromatography (RP-HPLC) method has been developed for the assay of ivermectin, including the determination and identification of its related substances in an ivermectin injectable product. Ivermectin and its related substances are adequately separated using a gradient elution at a flow rate of 1.5 mL/min on a Zorbax Extend-C18 column (150 × 4.6 mm i.d., 3.5 µm particle size) maintained at 30 °C. Mobile phase-A is composed of water and mobile phase-B is composed of acetonitrile/methanol (85/15, v/v). Analytes were monitored by UV detection at 245 nm. The stability-indicating capability of the method has been demonstrated by adequately separating the degradation products from the stress degraded samples of the ivermectin injectable product. The analytical performance of the method was validated as per the current ICH guidelines with respect to specificity, linearity (R² > 0.999), accuracy, precision, detection limit (0.3 µg/mL), quantitation limit (1.0 µg/mL), and robustness. This newly developed HPLC method for assay of ivermectin and determination of its related substances can be used to increase the throughput of a quality control (QC) lab for analytical testing of ivermectin injectable products.

伊维菌素注射剂产品广泛用作杀寄生虫剂，用于治疗和控制牛和猪的内外寄生虫。开发了一种反相高效液相色谱 (RP-HPLC) 方法，用于测定伊维菌素，包括测定和鉴定伊维菌素注射剂产品中的相关物质。在保持在 30 °C 的 Zorbax Extend-C18 色谱柱（150 × 4.6 mm 内径，3.5 µm 粒径）上，使用梯度洗脱以 1.5 mL/min 的流速充分分离伊维菌素及其相关物质。流动相-A 由水组成，流动相-B 由乙腈/甲醇 (85/15, v/v) 组成。通过紫外检测在 245 nm 处监测分析物。通过将降解产物与伊维菌素注射产品的应力降解样品充分分离，证明了该方法的稳定性指示能力。该方法的分析性能根据当前 ICH 指南在特异性、线性方面得到验证（R ²  > 0.999)、准确度、精密度、检测限 (0.3 µg/mL)、定量限 (1.0 µg/mL) 和稳健性。这种新开发的用于分析伊维菌素及其相关物质的 HPLC 方法可用于提高质量控制 (QC) 实验室对伊维菌素注射剂产品进行分析测试的吞吐量。