Step-by-step optimization of the HILIC method for simultaneous determination of abacavir, lamivudine, and zidovudine from dosage form

Step-by-step optimization of the HILIC method for simultaneous determination of abacavir, lamivudine, and zidovudine from dosage form

Combined therapy for HIV treatment shows superior efficacy in comparison to single therapy. Furthermore,the separation and determination of the combined dosage forms hold a significant place in the pharmaceutical industry.Not only reverse phase high-performance liquid chromatography (HPLC) but also hydrophilic interaction liquid chromatography (HILIC) can be used for these purposes. Contrary to conventional RP systems, HILIC may be an alternativefor the analysis of polar substances. The aim of this study was the step-by-step development of a simple, rapid, andreliable method for the simultaneous determination of antiviral compounds from their marketed formulation (Trizivir).In order to achieve this goal, various mobile phase systems, buffer types, and concentrations were prepared to provide anappropriate separation. Different types of columns were tested to find the best resolution and high efficiency for the studied compounds. The proposed method provided a simple procedure for the simultaneous analysis of abacavir, lamivudine,and zidovudine in their pharmaceutical preparation within approximately 2 min using the conventional HPLC system.The developed method was fully validated according to the International Council for Harmonisation guidelines from theviewpoint of selectivity, sensitivity, precision, accuracy, linearity, limit of detection, and quantification.

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  • 1. Shao HJ, Crump JA, Ramadhani HO, Uiso LO, Ole-Nguyaine S et al. Early versus delayed fixed dose combination abacavir/lamivudine/zidovudine in patients with HIV and tuberculosis in Tanzania. AIDS Research and Human Retroviruses 2009; 25: 1277-1285.
  • 2. Bernal J, Ares AM, Pol J, Wiedmer SK. Hydrophilic interaction liquid chromatography in food analysis. Journal of Chromatography A 2011; 1218: 7438-7452.
  • 3. Abafe OA, Späth J, Fick J, Jansson S, Buckley C et al. LC-MS/MS determination of antiretroviral drugs in influents and effluents from wastewater treatment plants in KwaZulu-Natal, South Africa. Chemosphere 2018; 200: 660-670.
  • 4. Kromdijk W, Pereira SA, Rosing H, Mulder JW, Beijnen JH et al. Development and validation of an assay for the simultaneous determination of zidovudine, abacavir, emtricitabine, lamivudine, tenofovir and ribavirin in human plasma using liquid chromatography-tandem mass spectrometry. Journal of Chromatography B 2013; 919-920: 43-51.
  • 5. Kumar DA, Rao GS, Rao JVLNS. Simultaneous determination of lamivudine, zidovudine and abacavir in tablet dosage forms by RP HPLC method. E-Journal of Chemistry 2010, 7:180-184.
  • 6. Djurdjevic P, Laban A, Markovic S, Jelikic-Stankov M. Chemometric optimization of a RP-HPLC method for the simultaneous analysis of abacavir, lamivudine, and zidovudine in tablets. Analytical Letters 2004; 37: 2649-2667.
  • 7. Greco G, Letzel T. Main interactions and influences of the chromatographic parameters in HILIC separations. Journal of Chromatographic Science 2013; 51: 684-693.
  • 8. Guo Y, Gaiki S. Retention and selectivity of stationary phases for hydrophilic interaction chromatography. Journal of Chromatography A 2011; 1218: 5920-5938.
  • 9. Dinh NP, Jonsson T, Irgum K. Probing the interaction mode in hydrophilic interaction chromatography. Journal of Chromatography A 2011; 1218: 5880-5891.
  • 10. Karatapanis AE, Fiamegos YC, Stalikas CD. A revisit to the retention mechanism of hydrophilic interaction liquid chromatography using model organic compounds. Journal of Chromatography A 2011; 1218: 2871-2879.
  • 11. McCalley DV. Study of the selectivity, retention mechanisms and performance of alternative silica-based stationary phases for separation of ionised solutes in hydrophilic interaction chromatography. Journal of Chromatography A 2010; 1217: 3408-3417.
  • 12. Bieke D, Yvan VH. HILIC methods in pharmaceutical analysis. Journal of Separation Science 2010; 33: 698-715.
  • 13. Nováková L, Svoboda P, Pavlík J. Ultra-high performance liquid chromatography. In: Fanali S, Haddad PR, Poole CF, Riekkola ML (editors). Liquid Chromatography (Second Edition). Amsterdam, the Netherlands: Elsevier, 2017, pp. 719-769.
  • 14. Amasya G, Gumustas M, Badilli U, Ozkan SA, Tarimci N. Development of a HILIC method for the determination of 5-fluorouracil from nano drug delivery systems and rat skin extracts. Journal of Pharmaceutical and Biomedical Analysis 2018; 154: 285-293.
  • 15. Sengel-Turk CT, Gumustas M, Uslu B, Ozkan SA. Nanosized drug carriers for oral delivery of anticancer compounds and the importance of the chromatographic techniques. In: Grumezescu AM (editor). Nano- and Microscale Drug Delivery Systems. Amsterdam, the Netherlands: Elsevier, 2017, pp. 165-195.
  • 16. Cavazzini A, Catani M, Felinger A. Hydrophilic interaction liquid chromatography. In: Fanali S, Haddad PR, Poole CF, Riekkola ML (editors). Liquid Chromatography (Second Edition). Amsterdam, the Netherlands: Elsevier, 2017, pp. 147-169.
  • 17. Dolzan MD, Spudeit DA, Breitbach ZS, Barber WE, Micke GA et al. Comparison of superficially porous and fully porous silica supports used for a cyclofructan 6 hydrophilic interaction liquid chromatographic stationary phase. Journal of Chromatography A 2014; 1365: 124-130.
  • 18. Hayes R, Ahmed A, Edge T, Zhang H. Core-shell particles: preparation, fundamentals and applications in high performance liquid chromatography. Journal of Chromatography A 2014; 1357: 36-52.
  • 19. Fanali S, D’Orazio G, Farkas T, Chankvetadze B. Comparative performance of capillary columns made with totally porous and core-shell particles coated with a polysaccharide-based chiral selector in nano-liquid chromatography and capillary electrochromatography. Journal of Chromatography A 2012; 1269: 136-142.
  • 20. International Conference on Harmonization. ICH Guidelines - Topic Validation of Analytical Procedures: Methodology. Brussels, Belgium: International Conference on Harmonization, 2005.
  • 21. International Conference on Harmonization. ICH Guidelines - Stability Testing of New Drug Substances and Products: Methodology. Geneva, Switzerland: International Conference on Harmonization, 2000.
Turkish Journal of Chemistry-Cover
  • ISSN: 1300-0527
  • Yayın Aralığı: Yılda 6 Sayı
  • Yayıncı: TÜBİTAK