Volume : 13, Issue : 10, October – 2026
Title:
A NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ANALYSIS OF TUCATINIB IN BULK AND MARKETED FORMULATION BY RP HPLC METHOD
Authors :
Adla Sangeetha*, M. Sruthi, Kondapally Chakravarthi, Kosgi Sowmya
Abstract :
An analytical, specific, accurate, precise, robust, efficient and simple RP-HPLC method has been developed and validated for the determination of Tucatinib in bulk and was applied on marketed Tucatinib products. The mobile phase used for the chromatographic runs consisted of Phosphate Buffer (0.02M) and Acetonitrile in the proportion of 48:52% with maintained at pH-2.80 by diluted OPA solution. The separation was achieved on a Symmetry ODS (C18) RP Column, 250 mm x 4.6 mm, 5µm column using isocratic mode. Drug peak were well separated and were detected by a UV detector at 248 nm. The method was linear at the concentration range 30–70 μg/ml for Tucatinib. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. Tucatinib limit of detection (LOD) and limit of quantification (LOQ) were 0.09μg/ml and 0.27μg/ml respectively.
Keywords: Tucatinib, RP-HPLC, Accuracy, Precision, Robustness, ICH Guidelines.
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Cite This Article:
Please cite this article in press Adla Sangeetha et al., A New Analytical Method Development And Validation For The Analysis Of Tucatinib In Bulk And Marketed Formulation By Rp Hplc Method.,. Indo Am. J. P. Sci, 2026; 13(10).
REFERENCES:
1. https://go.drugbank.com/drugs/DB11652
2. https://pubchem.ncbi.nlm.nih.gov/compound/Tucatinib
3. https://en.wikipedia.org/wiki/Tucatinib
4. R. Snyder, J. Kirkland, L. Glajch, Practical HPLC Method Development, john Wiley and sons International publication, II Edn., 2011.
5. S. Ashutoshkar, Pharmaceutical Drug Analysis 2nd Edn, New Age International Private Limited Publishers, 452-474, 2005.
6. H. Beckett and J.B. Stenlake, Practical Pharmaceutical Chemistry, 4th End. C.B.S. Publishers and Distributors’, New Delhi. 1-9, 157-167.
7. H.H. Williard, L.L. Merit, F.A. Dean, F.A. Settle, Instrumental Methods Of Analysis, 6th Edn, C.B.S. Publishers and Distributors, New Delhi.: 430-440, 495-504,529-545.
8. B.K. Sharma, Instrumental Methods of Chemical Analysis. GOEL Publishing House, Meerut: 286-300.
9. Instant notes on analytical chemistry by D. Kealey and P.J. Haines, © BIOS Scientific Publishers Limited, UK, 6-7, 2002.
10. Gurdeep R. Chatwal, Sham K. Anand, Instrumental methods of Chemical Analysis,5th edition, Himalaya Publishing House(Mumbai), P-2.566, 2005,.
11. M. E. Swartz, Journal of liquid chromatography, 28(7/8), 1253-1263(2005).
12. Journal of Chromatography .B, Analytical Technologies in the Biomedical and life Sciences. 2008 March 1; 863(2): 258-265. Published on Jan 18 2008.
13. International Conference on Harmonization, Harmonized Tripartite Guideline. Validation of Analytical Procedures. Text and Methodology. Q2 (R1). November 2005.
14. International Conference on Harmonization (ICH). Validation of Analytical Methods: Definitions and Terminology. ICH Q2A. 1994.
15. J. M. Green, a practical guide to analytical method validation, anal. Chem. News & features, pp. 305a–309a, 1 may 1996.
16. P. A. Winslow and r. F. Meyer, defining a master plan for the validation of analytical methods, j. Validation technology, pp. 361–367, 1997.
17. Aoac peer-verified methods program, manual on policies and procedures, Arlington, Va., USA (1998).
18. R. Patil: J of Chromatographia, 67, 575, (2008).
19. Baht and Leena: J of Liq. Chrom., 30, 309, (2007).
20. H.H. Williard, L.L. Merit, F.A. Dean and F.A. Settle, Instrumental methods of analysis, 7th edition, C.B.S. Publishers, New Delhi, 2002.
21. GN Menon, LB White, Department of Analytical Research, Abbott Laboratories, (pub med-index for MEDLINE).
22. Food and Drug Administration (FDA), “Analytical Procedures and Methods Validation: Chemistry, Manufacturing and Controls Documentation;” Federal Register (Notices), Vol: 65 (169), 52776–52777, 2000.
23. Vibha G et al., Development and validation of HPLC method – a review. International Research Journal of Pharmaceutical and Applied Sciences. 2012, 2(4), 22-23.
24. Bliesner DM. In: Validating Chromatographic Methods. John Wiley & sons Inc. 2006, 88-92.
25. Validation of Analytical Procedures: Methodology. ICH-Guidelines Q2B, Geneva. 1996, 11. (CPMP/ICH/281/95).
26. Development and validation of HPLC method – A Review, Vibha Gupta et al, International Research Journal of Pharmaceutical and Applied Sciences, 2012; 2(4):17-25.
27. A Review: HPLC Method Development and Validation, Santosh Kumar Bhardwaj *et al. International Journal of Analytical and Bioanalytical Chemistry, accepted 20 November 2015.
28. Method Development: A Guide to Basics Quantitative & Qualitative HPLC, LC, GC ChromAcademy.
29. Lalit V Sonawane* Bioanalytical Method Validation and Its Pharmaceutical Application- A Review Pharmaceutica Analytical Acta 2014, 5:3Center for Drug Evaluation and Research (CDER) Reviewer Guidance.
30. ICH Topic Q 2 (R1) Validation of Analytical Procedures: Text and Methodology.
31. S. K. Reehana1*, K. Sujana1, LC-MS/MS Characterization of Forced Degradation Products of Tucatinib, a Novel Tyrosine Kinase Inhibitor: Development and Validation of Rp-Hplc Method, International Journal of Applied Pharmaceutics, Vol 14, and Issue 1, 2022, 58-66.
32. Bandaru Venkata Ramarao, Anand Solomon Kamalakaran*, Development and validation of an LC-MS/MS method for pharmacokinetic assessment of Tucatinib in rat plasma, Journal of Applied Pharmaceutical Science, Vol. 15(04), pp 225-233, April, 2025.