Comparation with Spectrophotometric and Liquid Chromatographic Methods of Pharmaceutical Forms of Ivermectin

Aim: Ivermectin is a semi-synthetic parasiticide that is used to treat parasitic disorders. Herein, In this study, LC chromatographic and UV spectrophotometric methods were developed and validated for the determination of ivermectin in different ivermectin preparations. Materials and Methods: In the LC chromatografic method, chromatographic separation was performed using an Agilent Extend-C18 column. Acetonitrile (20/80, v/v) and ultra-pure water was used as mobile phase at a flow rate of 1.2 mL/min. Eluents were determined at a wavelength of 245 nm and the values of ivermectin solutions were detected by spectrophotometric technique at the same wavelength. Lambert−Beer plots showed linear relationships at 6 different concentrations in the range of 10 to 60 μg/mL. Both methods adhered to the protocols published by ICH guidelines Q2(R1) to validate analytical methods. Results: The developed analytic methods were statistically validated. As a result of the analyzes performed with spectrophotometric and liquid chromatographic methods, it was determined that both methods were precise, accurate and robust with a RSD < 1% result. Recovery values were within the normal range (98-100%). Statistical comparison of both analytical methods was made and there was no statistical significance between them. Conclusion: These developed methods have been found to be reliable, fast, accurate and simple for tablet and injectable ivermectin forms and can be used for quality control tests. HPLC and UV spectrophotometric methods have shown that they are both adequate to determine the amount of ivermectin in raw materials, tablets and injectable solutions. These methods can be applied in a short time and easily. They can be used successfully in quality control analyzes to quantify and identify ivermectin in marketed formulations.

Keywords:

Ivermektin, HPLC, UV, Yöntem Validasyon,

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