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

Year 2023, Volume: 5 Issue: 1, 126 - 31, 15.01.2023

Numan Taşpınar

https://doi.org/10.37990/medr.1183807

Cited By: 1

Abstract

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

Thanks

I would like to thank İbrahim BULDUK for not only giving the opportunity to work in the laboratory, but also for guiding this experimental study.

References

• 1. Group RC, Horby P, Lim WS, et al. Dexamethasone in Hospitalized Patients with Covid-19. N Engl J Med. 2021;384:693-704.
• 2. Barrows NJ, Campos RK, Powell ST, et al. A Screen of FDA-Approved Drugs for Inhibitors of Zika Virus Infection. Cell Host Microbe. 2016;20:259-70.
• 3. Conterno LO, Turchi MD, Correa I, Monteiro de Barros Almeida RA. Anthelmintic drugs for treating ascariasis. Cochrane Database Syst Rev. 2020;4:CD010599.
• 4. World Health Organization, 21st Model List of Essential Medicines. Geneva, Switzerland2019 [Available from: https://www.who.int/publications/i/item/WHOMVPEMPIAU 2019.06.
• 5. Nicolas P, Maia MF, Bassat Q, et al. Safety of oral ivermectin during pregnancy: a systematic review and meta-analysis. Lancet Glob Health. 2020;8:e92-e100.
• 6. Mastrangelo E, Pezzullo M, De Burghgraeve T, ion specifically targeting NS3 helicase activity: new prospects for an old drug. J Antimicrob Chemother. 2012;67:1884-94.
• 7. Wagstaff KM, Sivakumaran H, Heaton SM, et al. Ivermectin is a specific inhibitor of importin α/β-mediated nuclear import able to inhibit replication of HIV-1 and dengue virus. Biochem J. 2012;443:851-6.
• 8. Varghese FS, Kaukinen P, Gläsker S, et al. Discovery of berberine, abamectin and ivermectin as antivirals against chikungunya and other alphaviruses. Antiviral Res. 2016;126:117-24.
• 9. Heidary F, Gharebaghi R. Ivermectin: a systematic review from antiviral effects to COVID-19 complementary regimen. J Antibiot (Tokyo). 2020;73:593-602.
• 10. Abend AM, Chung L, McCollum DG, Wuelfing WP. Development and validation of an automated extraction method (accelerated solvent extraction) and a reverse-phase HPLC analysis method for assay of ivermectin in a meat-based chewable formulation. J Pharm Biomed Anal. 2003;31:1177-83.
• 11. Kitzman D, Wei SY, Fleckenstein L. Liquid chromatographic assay of ivermectin in human plasma for application to clinical pharmacokinetic studies. J Pharm Biomed Anal. 2006;40:1013-20.
• 12. Shurbaji M, Abu Al Rub MH, Saket MM, et al. Development and validation of a new HPLC-UV method for the simultaneous determination of triclabendazole and ivermectin B1a in a pharmaceutical formulation. J AOAC Int. 2010;93:1868-73.
• 13. Saad AS, Ismail NS, Soliman M, Zaazaa HE. Validated stability-indicating rp-hplc method for simultaneous determination of clorsulon and ivermectin employing plackett-burman experimental design for robustness testing. J AOAC Int. 2016;99:571-8.
• 14. Devaka NVSK, Rao VM. Chromatographic quantification of ivermectin and pranziquantel in the tablets using stability indicating RP-HPLC method. Pharm Sci. 2019;25:254-61.
• 15. Croubels S, De Baere S, Cherlet M, De Backer P. Determination of ivermectin B(1a) in animal plasma by liquid chromatography combined with electrospray ionization mass spectrometry. J Mass Spectrom. 2002;37:840-7.
• 16. Ali M, Alam S, Ahmad S, et al. Determination of ivermectin stability by high-performance thin-layer chromatography. International Journal of Drug Development and Research. 2011;3:240-7.
• 17. Wani GP, Jadhav SB. RP-HPLC and HPTLC stability indicating assay methods for ivermectin in bulk and tablet dosage form. Indian Drugs. 2018;55:32-42.
• 18. Chhonker YS, Ma L, Edi C, Murry DJ. A sensitive and selective LC-MS/MS method for quantitation of ivermectin in human, mouse and monkey plasma: clinical validation. Bioanalysis. 2018;10:1841-52.
• 19. Ortiz AJ, Cortez V, Azzouz A, Verdú JR. Isolation and determination of ivermectin in post-mortem and in vivo tissues of dung beetles using a continuous solid phase extraction method followed by LC-ESI+-MS/MS. PLoS One. 2017;12:e0172202.
• 20. Ivermectin. European Pharmacopoeia. 10th2021.
• 21. Ivermectin Injection. United States Pharmacopeia. 2021
• 22. ICH Q2(R1) 2005 [Available from: http://www.ich.org/page/qualityguidelines.