International Journal of Medical and All Body Health Research  |  e-ISSN: 2582-8940  |  Double-Blind Peer Review  |  Open Access  |  CC BY-NC-SA 4.0

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     2026:7/4

International Journal of Medical and All Body Health Research

e-ISSN: 2582-8940 | Open Access

A new analytical novel RP-HPLC method development and validation for the quantitative determination of Dasatinib in pure form and marketed pharmaceutical dosage form

Sumera Iram, Yerragolla Nuthana, Marella Shireesha, Kondoju Sai Teja, Somoju Sairam Chary

Assistant Professor, Department of Pharmacy Practice, Sree Dattha Institute of Pharmacy, Sheriguda (V), Ibrahimpatnam (M), Ranga Reddy, Telangana, India; Department of Pharmaceutical Analysis, Sree Dattha Institute of Pharmacy, Sagar Road, Sheriguda, Ibrahimpatnam, Telangana, India

Article Information

Volume / Issue5 / 2 (April-June 2024)
Pages31-37
AccessOpen Access

Publication Timeline

  • Received08 March 2024
  • Accepted10 April 2024

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Abstract

The present work includes a simple, economic, rapid, accurate and precise isocratic RP-HPLC method development for estimation of Dasatinib in bulk form and its marketed formulation. Estimation was done at 286nm which was found to be λmax of Dasatinib. The simple, selective, isocratic RP-HPLC method for Dasatinib was developed on Phenomenex Luna (C18) RP Column; 250 mm x 4.6 mm, 5µm with a mobile phase of Phosphate Buffer (pH-4.6) and Methanol were taken in the ratio of 65:35% v/v at a flow rate of 1.0 ml/min and detection wavelength 286nm. The developed method was validated successfully according to ICH Q2 (R1) guidelines. The chromatographic methods showed a good linear response with r2 values of 0.9995. The percentage relative standard deviation for method was found to be less than two, indicating that the methods were precise. The mean percentage recovery was for RP-HPLC method was 100.437%. From the results it could be concluded that both the developed method was specific, selective and robust. The method could be successfully applied for analysis of Bulk form and Marketed formulation of Dasatinib. 

Keywords

DasatinibRP-HPLCMethod DevelopmentValidationICH Guidelines

References

  1. DrugBank. Dasatinib. Available from: https://go.drugbank.com/drugs/DB01254 [Google Scholar][Crossref]
  2. PubChem. Dasatinib. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Dasatinib [Google Scholar][Crossref]
  3. Wikipedia. Dasatinib. Available from: https://en.wikipedia.org/wiki/Dasatinib [Google Scholar][Crossref]
  4. Skoog DA, Holler FJ, Nieman TA. Principles of Instrumental Analysis. 5th ed. Harcourt Publishes Int Company; Chapter 28, p. 726-766. [Google Scholar][Crossref]
  5. Neue UD. HPLC Columns: Theory, Technology and Practice. Wiley-VC. [Google Scholar][Crossref]
  6. Katz E, Eksteen R, Schoenmakers P, Miller N. Handbook of HPLC. Vol. 78. Marcel Dekker Inc. [Google Scholar][Crossref]
  7. Ewing GW. Instrumental Methods of Chemical Analysis. 5th ed. McGraw Hill Book Company; 1988. [Google Scholar][Crossref]
  8. Fong GW, Long PL. HPLC in Pharmaceutical Industry. Marcel Dekker Series. [Google Scholar][Crossref]
  9. Chatwal GR, Anand SK. Instrumental Methods of Chemical Analysis. Himalaya Publishing House; p. 615-623. [Google Scholar][Crossref]
  10. Kealey D, Haines PJ. Analytical Chemistry. 1st ed. BIOS Scientific Publishers; 2002. p. 1-7. [Google Scholar][Crossref]
  11. Beckett AH, Stenlake JB. Practical Pharmaceutical Chemistry. 4th ed. CBS Publishers and Distributors; p. 157-174. [Google Scholar][Crossref]
  12. Government of India, Ministry of Health and Family Welfare. Indian Pharmacopoeia. Vol. 2. Delhi: Publication by Controller of Publication, 2007, pp. 484– 554. [Google Scholar][Crossref]
  13. British Pharmacopoeia. International Ed. Vol. 1:429, 483. Published on the Recommendation of the Medicines Commissions Pursuant to Medicines Act 1968; 1993. [Google Scholar][Crossref]
  14. United States Pharmacopoeia 29 NF 24. Published on the Recommendation of the Medicines Commissions Pursuant to Medicines Act; p. 587. [Google Scholar][Crossref]
  15. Skoog DA, West DM, Holler FJ, Crouch SR. Fundamentals of Analytical Chemistry. 8th ed. Cengage Learning India Pvt Ltd; 2009. p. 271-280. [Google Scholar][Crossref]
  16. Kasture AV, Mahadik KR, Wadodkar SG, More HN. A Textbook of Pharmaceutical Analysis, Instrumental Methods. 9th ed. Nirali Prakashan; vol. 2, p. 5-7, 28-30. [Google Scholar][Crossref]
  17. Settle FA. Handbook of Instrumental Techniques for Analytical Chemistry. 1st ed. Singapore: Pearson Education Inc.; 2004. [Google Scholar][Crossref]
  18. Willard HH, Dean AJ. Instrumental Methods of Analysis. 7th ed. CBS Publishers and Distributors; 1986. p. 513-515. [Google Scholar][Crossref]
  19. Connors KA. A Textbook of Pharmaceutical Analysis. 3rd ed. Wiley Interscience Publication; 2005. p. 373-400. [Google Scholar][Crossref]
  20. Ahuja S. High Pressure Liquid Chromatography of Comprehensive Analytical Chemistry. Elsevier Publications; 2006. [Google Scholar][Crossref]
  21. Amesham Biosciences. Principles and Methods of Reversed Phase Chromatography. p. 6-8. [Google Scholar][Crossref]
  22. Snyder LR, Kirkland JJ, Glajch JL. Practical HPLC Method Development. 2nd ed. John Wiley and Sons Inc.; 1997. [Google Scholar][Crossref]
  23. Mohammad T, Pandya K, Zaveri M, Sathe P. HPLC Method Development and Validation for Pharmaceutical Analysis: A Review. Int Pharmaceutica Sciencia. 2012; 2(3):14. [Google Scholar][Crossref]
  24. Snyder LR, Kirkland JJ, Glajch JL. Practical HPLC Method Development. 2nd ed. Wiley; 2001. [Google Scholar][Crossref]
  25. Gupta V, Jain AD, Gill NS, Gupta K. Development and validation of HPLC method: A review. Int Res J Pharm Appl Sci. 2012; 2(4):22-23. [Google Scholar][Crossref]
  26. Bliesner DM. Validating Chromatographic Methods. John Wiley & Sons Inc.; 2006. p. 88-92. [Google Scholar][Crossref]
  27. International Conference on Harmonization (ICH). Validation of Analytical Procedures: Methodology. ICH Guidelines Q2B; 1996. p. 11. (CPMP/ICH/281/95). [Google Scholar][Crossref]
  28. Gupta V, Jain AD, Gill NS, Gupta K. Development and validation of HPLC method: A review. Int Res J Pharm Appl Sci. 2012; 2(4):17-25. [Google Scholar][Crossref]
  29. Bhardwaj SK, Dwivedi K, Agarwal D, Pathak N, Agarwal D. A Review: HPLC Method Development and Validation. Int J Anal Bioanal Chem. 2015. [Google Scholar][Crossref]
  30. Chromacademy. Method Development: A Guide to Basics Quantitative & Qualitative HPLC, LC, GC. [Google Scholar][Crossref]
  31. Sonawane LV. Bioanalytical Method Validation and Its Pharmaceutical Application: A Review. Pharm Anal Acta. 2014; 5(3). [Google Scholar][Crossref]
  32. International Conference on Harmonization (ICH). Validation of Analytical Procedures: Text and Methodology. ICH Guidelines Q2 (R1). [Google Scholar][Crossref]
  33. Sankar PR, Anusha S. Development and Validation of RP-HPLC Method for the Determination of Dasatinib in Tablet Dosage Form. Int J Pharm Sci Res. 2019; 10(10):4531-4537. [Google Scholar][Crossref]
  34. Ramachandra B, Naidu NV. Validation of RP-HPLC International Journal of Medical and All Body Health Research www.allmedicaljournal.com Method for Estimation of Dasatinib in Bulk and Its Pharmaceutical Dosage Forms. Int J Pharm Biol Sci. 2014; 4(1):61-68. [Google Scholar][Crossref]
  35. Jogarao YSRV, Bharath P, Siva Ramakrishna V, Ramachandran D. Development & Validation of RP-HPLC Method for Quantitative Estimation of Dasatinib and Its Impurities in Pharmaceutical Dosage Form. J Pharm Res Int. 2022; 34(25A):52-65. DOI: 10.9734/jpri/2022/v34i25A35950. [Google Scholar][Crossref]
  36. Nataraj KS, Sivalingachari P, Sai Naveen K, Alekhya K. Method Development and Validation for the Estimation of Dasatinib Monohydrate Tablets by RP-HPLC. Asian J Res Chem. 2013; 6(9):859-862. Copyright and License © The Author(s). Authors retain the copyright of their published articles. This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution Non Commercial-Share A like 4.0 International (CC BY-NC-SA 4.0) License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms. [Google Scholar][Crossref]

How to Cite

Iram, S., Nuthana, Y., Shireesha, M., Teja, K. S., & Chary, S. S. (2024). A new analytical novel RP-HPLC method development and validation for the quantitative determination of Dasatinib in pure form and marketed pharmaceutical dosage form. International Journal of Medical and All Body Health Research, 5(2), 31-37.

Iram, Sumera, et al. "A new analytical novel RP-HPLC method development and validation for the quantitative determination of Dasatinib in pure form and marketed pharmaceutical dosage form." International Journal of Medical and All Body Health Research, vol. 5, no. 2, 2024, pp. 31-37.

Iram, S., Nuthana, Y., Shireesha, M., Teja, K. S. and Chary, S. S. (2024) 'A new analytical novel RP-HPLC method development and validation for the quantitative determination of Dasatinib in pure form and marketed pharmaceutical dosage form', International Journal of Medical and All Body Health Research, 5(2), pp. 31-37.

Iram S, Nuthana Y, Shireesha M, Teja KS, Chary SS. A new analytical novel RP-HPLC method development and validation for the quantitative determination of Dasatinib in pure form and marketed pharmaceutical dosage form. International Journal of Medical and All Body Health Research. 2024;5(2):31-37.

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