Analytical and Bioanalytical HPLC Method for Simultaneous estimation of 5-Fluorouracil and Sonidegib

Abstract

Aim: To develop a new sensitive RP-HPLC method for simultaneous estimation of 5-fluorouracil (5-FU) and sonidegib (SDG). Materials & methods: Analytical and bioanalytical methods for simultaneous quantification of 5-FU and SDG in bulk, nanoformulations and in rat plasma were developed and validated using a gradient elution technique. Results: Separation of the analytes was effected on a Luna^® C18 LC column using a mobile mixture comprising acetonitrile and acidified water. 5-FU and SDG were extracted from plasma matrix using liquid–liquid extraction. The applicability of the method was verified through single-dose oral pharmacokinetic study in Wistar rats. Conclusion: The developed methods allow a specific, sensitive and steady analytical procedure for the simultaneous estimation of 5-FU and SDG in nanoformulations and biological matrix.

Keywords:

• 5-fluorouracil
• bioanalytical
• RP-HPLC
• simultaneous estimation
• sonidegib

Acknowledgments

The authors are thankful to: All India Council for Technical Education (AICTE), Government of India, New Delhi for providing National Doctoral Fellowship to Bharath Singh Padya; and Department of Science and Technology (DST), Government of India, New Delhi for providing DST-INSPIRE Fellowship to Sadhana P Mutalik.

Financial & competing interests disclosure

The authors also thank Manipal College of Pharmaceutical Sciences and Manipal Academy of Higher Education, Manipal for providing financial support and research facilities. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.