Simultaneous determination of ivermectin, clorsulon and their related substances in an injectable finished product by a stability-indicating RP-HPLC method

Abstract

A reversed-phase high performance liquid chromatography (RP-HPLC) method has been developed for the determination of ivermectin and clorsulon, including the identification and estimation of their related impurities in an ivermectin and clorsulon injectable finished product. Chromatographic separation was achieved using a gradient elution on a Supelco Ascentis® Express C18 column (150 mm × 4.6 mm i.d., 5 µm particle size) maintained at 55 °C. Mobile phase-A is composed of water and mobile phase-B is composed of acetonitrile/methanol (65/35, v/v). Analytes were monitored by UV detection at 245 nm. The stability-indicating capability of this method has been demonstrated by the adequate separation of all the process related impurities and degradation products of ivermectin and clorsulon from the stress degraded samples of the injectable product. This method was also successfully validated as per the current ICH guidelines with respect to specificity, linearity (R2> 0.999), limit of detection (0.3 μg/mL), limit of quantitation (1.0 μg/mL), accuracy, precision, and robustness for both APIs. This proposed method can significantly benefit the end-users in QC laboratories with laboratory efficiency and throughput during routine analysis and stability monitoring of the injectable product.