DEVELOPMENT AND VALIDATION OF NOVEL UV-VISIBLE SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF TEPOTINIB IN BULK AND IN PHARMACEUTICAL FORMULATION

MONIKA SHIRWAR; SHUBHANGI BIRAJDAR; SHRUTI GARAD; SMITA KUMBHAR

doi:10.22159/ijpps.2023v15i9.48431

Authors

MONIKA SHIRWAR Department of Pharmaceutical Quality Assurance, D. S. T. S. Mandal’s College of Pharmacy, Solapur, Maharashtra, India https://orcid.org/0009-0002-8907-7567
SHUBHANGI BIRAJDAR Department of Pharmaceutical Quality Assurance, D. S. T. S. Mandal’s College of Pharmacy, Solapur, Maharashtra, India https://orcid.org/0009-0006-7526-7174
SHRUTI GARAD Department of Pharmaceutics, D. S. T. S. Mandal’s College of Pharmacy, Solapur, Maharashtra, India
SMITA KUMBHAR Department of Pharmaceutical Chemistry, D. S. T. S. Mandal’s College of Pharmacy, Solapur, Maharashtra, India https://orcid.org/0000-0002-3030-9477

DOI:

https://doi.org/10.22159/ijpps.2023v15i9.48431

Keywords:

Tepotinib, UV spectrophotometer, Methanol, Validation, International council for Harmonization guidelines

Abstract

Objective: The objective of the study is to develop a new, simple, rapid, accurate, and economical UV-spectrophotometric method and validate the same for the estimation of Tepotinib in bulk and in pharmaceutical formulation as per ICH guidelines.

Methods: The present work was carried out using the UV-Visible double-beam spectrophotometer model Systronics 2201. Tepotinib was found soluble in water, methanol, methanol so, analytical-grade methanol was used as a solvent for conducting the work. The λ_max of the tepotinib was determined by dissolving pure drug in methanol scanned in the range of 200-800 nm. The present method was validated for the linearity, accuracy, precision, Limit of Detection and Limit of Quantification.

Results: The maximum absorbance of tepotinib obtained at a wavelength of 272 nm. The method was found linear in the range of 3-15 µg/ml with the regression coefficient of 0.996 and the equation y = 0.0699x+0.0335. The accuracy was found to be in the range of 96.8-98.5%, the intra-day and inter-day precision % RSD value was 0.262 and 0.69, respectively and the LOD and LOQ were 0.0925 µg/ml and 0.28 µg/ml respectively.

Conclusion: The method demonstrated good reproducibility and recovery so, proposed method can be successfully applied for the routine analysis of tepotinib in bulk and pharmaceutical dosage form.

Downloads

Download data is not yet available.

References

Markham A. Tepotinib: First approval. Drugs. 2020;80(8):829-33. doi: 10.1007/s40265-020-01317-9, PMID 32361823.

Paik PK, Felip E, Veillon R, Sakai H, Cortot AB, Garassino MC. Tepotinib in non-small-cell lung cancer with MET Exon 14 skipping mutations. N Engl J Med. 2020;383(10):931-43. doi: 10.1056/NEJMoa2004407, PMID 32469185.

Raviteja G. Method development and validation of tepotinib by using reverse phase liquid chromatography in bulk and pharmaceutical dosage form. Biosc Biotech Res Comm. 2021;14:350-4.

Vijaya Sri K. Method development and validation for the estimation of tepotinib in pharmaceutical dosage forms by RP-HPLC. Int J Pharm Pharm Res Hum. 2022;26(1):468-77.

Hesham S, Noha A, Bahaa O, Abdel R. Approved spectrofluorometric strategies for assurance of the three antineoplastic drugs: tepotinib, Sotorasib, and darolutamide in their dosage forms and biological liquids using mercurochrome. Luminescence. 2022 Apr;37(4):656-64. doi: 10.1002/bio.4206.

Ramachandran D. Bioanalytical method development and validation of tepotinib in rat plasma with LC-MS/MS. J Cardiovasc Dis Res. 2021;12(4):1413-9.

International Conference of Harmonization. Validation of Analytical Procedures: text and methodology. Vol. Q2(R1). Geneva, Switzerland: ICH; 2005.

Ioele G, Chieffallo M, Occhiuzzi MA, De Luca M, Garofalo A, Ragno G. Anticancer drugs: recent strategies to improve stability profile, pharmacokinetic and pharmacodynamic properties. Molecules. 2022 Aug 25;27(17):5436. doi: 10.3390/molecules27175436, PMID 36080203.

Pirro E, De Francia S, De Martino F, Fava C, Ulisciani S, Cambrin GR. A new HPLC-UV validated method for therapeutic drug monitoring of tyrosine kinase inhibitors in leukemic patients. J Chromatogr Sci. 2011 Nov-Dec;49(10):753-7. doi: 10.1093/chrsci/49.10.753, PMID 22080802.

Sawale VS, Umamaheshwari D. A review on novel analytical techniques used in method development and validation of pharmaceuticals. J Pharm Sci Res. 2020;12(2):321-8.

Sharma S, Goyal S, Chauhan K. A review on analytical method development and validation. Int J App Pharm. 2018 Nov 7;10(6):8-15. doi: 10.22159/ijap.2018v10i6.28279.

Gadekar Y, Pawar P, Katkade P, Pawar V. A review: analytical method development and validation. Int Pharm Res Appl. 2023;8(1):1380-9.

Ramole R, Baile M. A review: analytical method development and validation. Syst Rev Pharm. 2021;12(8):450-4.

Bende G, Kollipara S, Sekar V, Saha R. UV-spectrophotometric determination of imatinib mesylate and its application in solubility studies. Pharmazie. 2008;63(9):641-5. PMID 18819515.

Venkateshwarlu P, Patel MM. A review: method development validation and degradation studies of some anticancer drugs. Res J Pharm Technol. 2021:5443-8. doi: 10.52711/0974-360X.2021.00949.

Ajithkumar P, Arul D, Anton S. Development of analytical method for imatinib mesylate by ultraviolet spectroscopy. Asian J Pharm Clin Res. 2019:180-3. doi: 10.22159/ajpcr.2020.v13i1.36098.

Velpandian T, Mathur R, Agarwal NK, Arora B, Kumar L, Gupta SK. Development and validation of a simple liquid chromatographic method with ultraviolet detection for the determination of imatinib in biological samples. J Chromatogr B Analyt Technol Biomed Life Sci. 2004;804(2):431-4. doi: 10.1016/j.jchromb.2004.01.032, PMID 15081939.

Atole DM, Rajput HH. Ultraviolet spectroscopy and its pharmaceutical applications-a brief review. Asian J Pharm Clin Res. 2018;11(2):59. doi: 10.22159/ajpcr.2018.v11i2.21361.

Nussbaumer S, Bonnabry P, Veuthey JL, Fleury Souverain S. Analysis of anticancer drugs: a review. Talanta. 2011;85(5):2265-89. doi: 10.1016/j.talanta.2011.08.034, PMID 21962644.

Rathod RD, Rathod LD, Mundada AB, Patel HM. Validated UV spectrophotometric methods for the determination of anticancer drug erlotinib hydrochloride in bulk and tablet formulations. J Appl Spectrosc. 2021;88(4):882-6. doi 10.1007/s10812-021-01254-9.

Mittha J, Habib B. UV spectrophotometric method development and validation of dasatinib in bulk and formulation. Asian J Pharm Anal. 2021;11(3):203-6. doi: 10.52711/2231-5675.2021.00036.