A Comprehensive New Approach to Method Development and Validation of Encorafenib using UV Spectroscopy in Bulk and Pharmaceutical Formulation

Year 2024, , 318 - 327, 01.12.2024

Anusha Gandi , Pavan Kumar Dudi , Eswar Sandeep Pantala , Varaprasada Rao K , Srinivasa Rao Yarguntla

https://doi.org/10.52794/hujpharm.1479058

Abstract

Encorafenib is a class of anti-cancer medication used to treat cancer infections. It is a selective BRAF inhibitor, has emerged as a promising therapeutic agent in the treatment of metastatic melanoma. This research endeavors to introduce a fresh approach and authenticate a UV spectrophotometric technique for examining encorafenib in pharmaceutical formulations. A unique, precise, and cost-effective UV spectrophotometric procedure has been devised using a blend of phosphate buffer and acetonitrile (90:10). Various standard solutions ranging from 10 to 70 μg/ml of the drug were evaluated for their absorbance at 235nm against a blank solution. The method exhibited a linear dynamic range of 10.0–70.0 µg/ml with an impressive correlation coefficient (r2=0.9996) and a regression equation of y =0.0102x-0.0049. Intra- and inter-precisions displayed relative standard deviations (RSD) below 2.0%. The limits of detection (LOD) and quantification (LOQ) were determined as 0.159 µg/ml and 0.483 µg/ml respectively. All validation parameters adhered to the stipulated limits outlined in ICH guidelines. This approach has the potential to be a valuable asset for regular quality assessment in pharmaceutical labs contributing to the assurance of safety and efficacy in medications containing Encorafenib.

Keywords

Encorafenib, UV Spectrophotometric method, Phosphate Buffer, Acetonitrile, Method validation

References

• 1. Al-Salama, Z. T. Encorafenib: a review in metastatic colorectal cancer with a braf V600E mutation. Drugs, 2021,81(7), 849-856.
• 2. US Food and Drug Administration. Prescribing information https://www. accessdata. fda. gov/drugsatfda_docs/label/2020/204114s016lbl. pdf.
• 3. Bellouard M, Donadieu J, Thiebot P, Giroux Leprieur E, Saiag P, Etting I, Dugues P, Abe E, Alvarez JC, Larabi IA. Validation of Liquid Chromatography Coupled with Tandem Mass Spectrometry for the Determination of 12 Tyrosine Kinase Inhibitors (TKIs) and Their Application to Therapeutic Drug Monitoring in Adult and Pediatric Populations. Pharmaceutics. 2023 Dec 19;16(1):5. https://doi.org/10.3390/pharmaceutics16010005
• 4. Myszkiewicz MF, Puzanov I, Goey AK. Development and validation of an LC–MS/MS method to measure the BRAF inhibitors dabrafenib and encorafenib quantitatively and four major metabolites semi-quantitatively in human plasma. J. Pharm. Biomed. Anal. 2023 Sep 20;234:115594. https://doi.org/10.1016/j.jpba.2023.115594
• 5. Attwa MW, Darwish HW, Al-Shakliah NS, Kadi AA. A validated lc–ms/ms assay for the simultaneous quantification of the fda-approved anticancer mixture (Encorafenib and binimetinib): Metabolic stability estimation. Molecules. 2021 May 5;26(9):2717. https://doi.org/10.3390/molecules26092717
• 6. Hefnawy MM, Alanazi MM, Al-Hossaini AM, Alnasser AI, El-Azab AS, Jardan YA, Attwa MW, El-Gendy MA. A Rapid and Sensitive Liquid Chromatography-Tandem Mass Spectrometry Bioanalytical Method for the Quantification of Encorafenib and Binimetinib as a First-Line Treatment for Advanced (Unresectable or Metastatic) Melanoma—Application to a Pharmacokinetic Study. Molecules. 2022 Dec 22;28(1):79. https://doi.org/10.3390/molecules28010079
• 7. Raveendranath TV, Saravanakumar RT, Male A. Stability-indicating Reversed Phase-Ultra Performance Liquid Chromatography Method Development and Validation for Simultaneous Determination of Encorafenib and Binimetinib in Formulation. Int. J. Pharm. Sci. Drug Res. 2020;12(5):488-94. https:// 10.25004/IJPSDR.2020.120509
• 8. Peter Mikus, Ladislav Novotny on the Importance of Pharmaceutical Analysis, J. Pharm. Anal. 2015, 4(3).
• 9. Importance of Pharmaceutical analysis by www.pharmatutor.org/Pharmaanalysis
• 10. Snyder LR, Kirkland JJ, Introduction to modern chromatographic techniques. 2nded. New York; John Wiley& Sons; 1979.
• 11. Spectroscopy by B.K Sharma GOEL publishing house, Meerut, Delhi.
• 12. Validation of Compendial Procedures 1225>, the United States Pharmacopeia, 32th Rev., and the National Formulary, 27th Rev., Rockville, MD: The United States Pharmacopeial Convention Inc., 2009; I: 735.
• 13. Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH Harmonized Tripartite guidelines, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals For Human Use, 2005; 10.
• 14. Validation of Analytical Procedures SC III F, British Pharmacopeia, British Pharmacopeia Commission, 2013.
• 15. Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH Harmonized Tripartite guidelines, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals For Human Use, 2005; 5.
• 16. Validation of Compendial Procedures 1225, The United States Pharmacopeia, 32th Rev., and The National Formulary, 27th Rev., Rockville, MD: The United States Pharmacopeial Convention Inc., 2009; I: 737.
• 17. Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH Harmonized Tripartite guidelines, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals For Human Use, 2005; 9.
• 18. Validation of Compendial Procedures 1225>, The United States Pharmacopeia, 32th Rev., and The National Formulary, 27th Rev., Rockville, MD: The United States Pharmacopeial Convention Inc., 2009; I: 738.