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Abstract

DEVELOPMENT AND VALIDATION OF AN ANALYTICAL METHOD FOR QUANTIFICATION OF IVERMECTIN ANALYSIS

Shiba S. Morris*, Md. Daneyal Khurshid and Anisha Arya

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Abstract

Ivermectin is a widely used drug in the treatment and prevention of various parasitic infections in humans and animals. To ensure its quality, safety, and efficacy, it is essential to develop and validate robust analytical methods for its analysis. This research paper aims to provide an overview of the analytical method development and validation parameters for the drug Ivermectin. We developed and validated an accurate, simple, comprehensive, selective, and rapid RPHPLC technique for the determination of ivermectin in the tablet dosage form. The reverse phase HPLC method was developed for routine measurement of ivermectin in laboratory-prepared mixtures and combination dose forms. Waters model 2489, Software-Empower 2 was utilized as the instrument. The chromatographic separation was carried out using an INERTSIL C-18 ODS 2504.6mm,5um particle size column with a mobile phase of acetonitrile and methanol flowing at a rate of 1ml/min. Quantification was performed using a UV detector set at 245nm for a 10-minute run period. Ivermectin had a retention time of 4.198 minutes. For ivermectin, linearity was found in the concentration range of 1-32g/ml with a correlation value of 0.9798. Intraday precision had a percent RSD of 1.6283 and interday precision had a percent RSD of 1.352. The LOQ and LOD values were determined to be 2.93 and 8.79, respectively, whereas the theoretical plates and tailing factor for ivermectin were determined to be 129.949 and 2.0, respectively. Robustness was also investigated, and it was shown that minor changes in experimental parameters had no substantial effect on the analytical method's system appropriateness. The method has been verified against ICH standards for linearity, precision, accuracy, and other characteristics. The findings produced by RP-HPLC techniques are rapid, detailed, selective, and accurate. As a result, the suggested method may be used to analyse ivermectin in injectable, tablet, and other formulations regularly. The paper discusses various aspects such as sample preparation, instrumental analysis, method validation, and quality control measures. The development and validation of accurate and reliable analytical methods for Ivermectin are crucial for its pharmaceutical and clinical applications.

Keywords: Ivermectin, analytical methods, method development, method validation, quality control, HPLC, pharmaceutical analysis.


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