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<p>Ivermectin is an antiparasitic drug used in human and animal pharmaceutical industries to treat a variety of external and internal parasites. A new reversed phase HPLC method has been developed for identification, assay, and estimation of related substances identified in bulk lots of Ivermectin drug substance. Analytes were separated on a fused-core silica particle-based Halo C18 column (150 × 4.6&#xa0;mm, 2.7&#xa0;µm particle size). A gradient elution at 40&#xa0;°C column temperature was employed to adequately separate all analytes of interest in the samples. The new method can separate 27 Ivermectin related substances peaks including the 26-epimer of H<sub>2</sub>B<sub>1a</sub> from H<sub>2</sub>B<sub>1a</sub> peak and H<sub>2</sub>B<sub>1a</sub> isomer-1 peak from H<sub>2</sub>B<sub>1b</sub> peak which together can account for about 2.5% of peak area percentage in a typical Ivermectin API batch. The runtime of the new HPLC method is much shorter compared to the runtime of the current USP and EP methods for Ivermectin drug substance. The quantitation limit of the method is 0.10% of target analytical concentration (~ 2&#xa0;mg/mL). The new method was demonstrated to be sensitive, accurate, and robust making it a (quality control) QC friendly method for routine and non-routine analysis of Ivermectin drug substance.</p>

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Development and Validation of a Stability Indicating Reversed-Phase HPLC Method for Simultaneous Determination of Ivermectin and Its Related Substances in Bulk Drug Substance Lots of Ivermectin

  • 期刊论文

  • 发表日期：

    2025年10月18日

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  • Isuri Jayasooriya,
  • Abu M. Rustum

摘要

Ivermectin is an antiparasitic drug used in human and animal pharmaceutical industries to treat a variety of external and internal parasites. A new reversed phase HPLC method has been developed for identification, assay, and estimation of related substances identified in bulk lots of Ivermectin drug substance. Analytes were separated on a fused-core silica particle-based Halo C18 column (150 × 4.6 mm, 2.7 µm particle size). A gradient elution at 40 °C column temperature was employed to adequately separate all analytes of interest in the samples. The new method can separate 27 Ivermectin related substances peaks including the 26-epimer of H2B1a from H2B1a peak and H2B1a isomer-1 peak from H2B1b peak which together can account for about 2.5% of peak area percentage in a typical Ivermectin API batch. The runtime of the new HPLC method is much shorter compared to the runtime of the current USP and EP methods for Ivermectin drug substance. The quantitation limit of the method is 0.10% of target analytical concentration (~ 2 mg/mL). The new method was demonstrated to be sensitive, accurate, and robust making it a (quality control) QC friendly method for routine and non-routine analysis of Ivermectin drug substance.