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

IF 1.6 4区化学 Q4 BIOCHEMICAL RESEARCH METHODS

Chromatographia Pub Date : 2025-10-18 DOI:10.1007/s10337-025-04426-3

Isuri Jayasooriya, Abu M. Rustum

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Abstract

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 H₂B_1a from H₂B_1a peak and H₂B_1a isomer-1 peak from H₂B_1b 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.

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稳定性指示反相高效液相色谱法同时测定原料药中伊维菌素及其相关物质的建立与验证

伊维菌素是一种抗寄生虫药物，用于人类和动物制药工业，治疗各种外部和内部寄生虫。建立了一种新的反相高效液相色谱法，用于大批量伊维菌素原料药中相关物质的鉴定、分析和估计。分析物在基于熔芯二氧化硅颗粒的Halo C18柱（150 × 4.6 mm， 2.7µm粒径）上分离。在40°C柱温下进行梯度洗脱，充分分离样品中所有感兴趣的分析物。新方法可分离出27个伊维菌素相关物质峰，包括H2B1a 26-表聚体与H2B1a峰、H2B1a异构体-1与H2B1b峰，约占典型伊维菌素原料药批次峰面积百分比的2.5%。与现行的伊维菌素原料药USP和EP方法相比，该方法的运行时间大大缩短。方法的定量限为目标分析浓度的0.10% （~ 2mg /mL）。结果表明，该方法灵敏、准确、鲁棒性好，可用于伊维菌素原料药的常规和非常规分析。

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来源期刊

Chromatographia 化学-分析化学

CiteScore

3.40

自引率

5.90%

发文量

103

审稿时长

2.2 months

期刊介绍： Separation sciences, in all their various forms such as chromatography, field-flow fractionation, and electrophoresis, provide some of the most powerful techniques in analytical chemistry and are applied within a number of important application areas, including archaeology, biotechnology, clinical, environmental, food, medical, petroleum, pharmaceutical, polymer and biopolymer research. Beyond serving analytical purposes, separation techniques are also used for preparative and process-scale applications. The scope and power of separation sciences is significantly extended by combination with spectroscopic detection methods (e.g., laser-based approaches, nuclear-magnetic resonance, Raman, chemiluminescence) and particularly, mass spectrometry, to create hyphenated techniques. In addition to exciting new developments in chromatography, such as ultra high-pressure systems, multidimensional separations, and high-temperature approaches, there have also been great advances in hybrid methods combining chromatography and electro-based separations, especially on the micro- and nanoscale. Integrated biological procedures (e.g., enzymatic, immunological, receptor-based assays) can also be part of the overall analytical process.