REVIEW ON METHOD DEVELOPMENT AND VALIDATION OF RP- HPLC TECHNIQUE FOR THE ESTIMATION OF IVERMECTIN FROM ANIMAL BODY FLUIDS

Gaurav G. Manwar*, Dr. Anand S. Khode, Rupeshri R. Netkar, Sonali A. Kantale

Ivermectin is a potent antiparasitic agent widely used in human and veterinary medicine. Accurate quantification of ivermectin in pharmaceutical dosage forms is essential for ensuring therapeutic efficacy, safety, and regulatory compliance. This review consolidates validated analytical methods—primarily reverse-phase high-performance liquid chromatography (RP-HPLC) and ultraviolet (UV) spectrophotometry—used for the estimation of ivermectin in bulk and combined formulations. It discusses method development strategies, validation parameters, and comparative performance metrics to guide researchers in establishing robust, reproducible, and regulatory-compliant analytical techniques. A selective, accurate, and stability-indicating reverse-phase high-performance liquid chromatographic (RPHPLC) method was developed and validated for the estimation of Ivermectin in pharmaceutical dosage forms. The method was designed to support routine quality control and formulation analysis, ensuring reliable quantification of Ivermectin in both pure drug and tablet preparations. Chromatographic separation was achieved using a C18 column with a mobile phase composed of acetonitrile and methanol. The system operated under optimized conditions with UV detection at a suitable wavelength for Ivermectin. The method was validated in accordance with ICH Q2(R1) guidelines, covering essential parameters such as specificity, accuracy, precision, robustness, and sensitivity. To confirm the method’s stability-indicating capability, Ivermectin samples were subjected to various stress conditions including acidic and basic hydrolysis, oxidative degradation, photolytic exposure, and thermal stress. The method successfully distinguished the active pharmaceutical ingredient from its degradation products, demonstrating its suitability for stability studies. Robustness testing revealed consistent performance despite minor variations in chromatographic conditions, affirming the method’s reliability in routine laboratory settings. The simplicity of the mobile phase and ease of sample preparation further enhance its practical utility. In conclusion, the developed RP-HPLC method is simple, specific, and reproducible, making it highly suitable for the regular analysis of Ivermectin in pharmaceutical formulations. Its stability-indicating nature ensures accurate assessment under diverse stress conditions, supporting its application in both research and industrial environments. The method’s compliance with regulatory standards and its operational efficiency make it a valuable tool for quality assurance in pharmaceutical analysis.