Application of Box-Behnken design for optimization of A RP-HPLC method for determination of palonosetron and netupitant in their combined dosage form in presence of their impurities

Abstract

The use of (Netupitant and Palonosetron) combination to treat nausea and vomiting in cancer chemotherapy patients has been authorized by the Food and Drug Administration. For the simultaneous determination of Netupitant (NET) and palonosetron (PAL) in the presence of two of their related substances and in their dosage form, a sensitive and selective RP-HPLC method has been developed and validated. The aforementioned medications were separated and quantified with the help of experimental design. The Box-Behnken design was used in the experiment to optimize the chromatographic method’s analytical parameters. It employed RP-HPLC with a UV detector. Waters ODS-C₁₈ column (3.5 µm, 75 × 4.6 mm) with a mobile phase composed of acetonitrile: 25 mM phosphate buffer (pH = 3.5) in a gradient mode at 254 nm was employed to separate the cited drugs and their impurities. Palonosetron was linear over the concentration range (1–50 µg/mL) and Netupitant (10–100 µg/mL). According to ICH guidelines, the new method underwent thorough validation. Between the proposed method’s results and those from the reported method, there was no significant difference. It is easy to apply the technique to the analysis of the specified drugs in their combination dosage form for quality control considerations.

Graphical Abstract

Keywords:

• Box-Behnken design
• netupitant
• palonosetron
• pharmaceutical preparation
• RP-HPLC

Correction Statement

This article has been corrected with minor changes. These changes do not impact the academic content of the article.

Authors contributions

Ehab F. ElKady and Eman A. Mostafa contributed to the study conception and design and interpretation of the data. Material preparation, data collection, and analysis were performed by Mohamed A. ElHamid and Eman A. Mostafa. The first draft of the manuscript was written by Eman A. Mostafa and Mohamed A. ElHamid and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.