Volume : 12, Issue : 06, June – 2025
Title:
DEVELOPMENT AND VALIDATION OF AN HPLC METHOD FOR DETECTION AND QUANTIFICATION OF MIDOSTAURIN IN BULK AND MARKETED PHARMACEUTICAL DOSAGE FORM
Authors :
CH .Kantlam , CH.Suchitra*, Dhara Shivanand, Farha Maheen, G.Veena, K. Bhavani, K.Saicharan
Abstract :
A simple, rapid, specific and accurate reverse phase high performance liquid chromatographic method has been developed for the validated of Midostaurin in bulk as well as in marketed pharmaceutical dosage form. This separation was performed on a Symmetry ODS (C18) RP Column, 250 mm x 4.6 mm, 5µm column with Acetonitrile, Methanol and 0.1% OPA in the ratio of 60:30:10 as mobile phase at a flow rate of 1.0 mL min−1 with UV detection at 235 nm; the constant column temperature was Ambient. The run time under these chromatographic conditions was less than 6.0 min. The retention time of Midostaurin was found to be 2.570min. The calibration plot was linear over the concentration range of 6–14 μg mL−1 with limits of detection and quantification values of 0.8 and 0.24ng mL−1 respectively. The mean % assay of marketed formulation was found to be 99.79%, and % recovery was observed in the range of 98-102%. Relative standard deviation for the precision study was found <2%.The developed method is simple, precise, specific, accurate and rapid, making it suitable for estimation of Midostaurin in bulk and marketed pharmaceutical dosage form dosage form.
Keywords: Midostaurin, RP-HPLC, Validation, Accuracy, Precision, Robustness, ICH Guidelines.
Cite This Article:
Please cite this article in press Ch .Kantlam et al., Development And Validation Of An Hplc Method For Detection And Quantification Of Midostaurin In Bulk And Marketed Pharmaceutical Dosage Form., Indo Am. J. P. Sci, 2025; 12(07).
Number of Downloads : 10
References:
1. https://go.drugbank.com/drugs/DB06595
2. https://pubchem.ncbi.nlm.nih.gov/compound/Midostaurin
3. https://en.wikipedia.org/wiki/Midostaurin
4. Morgan, David J., “Fraction collector (post on Flickr)”. Flickr. Retrieved, 28 October 2015.
5. Karger, Barry L. “HPLC: Early and Recent Perspectives”. Journal of Chemical Education. 74: 45. Bibcode: 1997JChEd.74…45K, 1997.
6. Henry, Richard A., “The Early Days of HPLC at Dupont”. Chromatography Online. Avanstar Communications Inc, 1 February 2009.
7. Iler, R.K., the Chemistry of Silica. John Wiley & Sons. New York, 1979.
8. Karger, B. L.; Berry, L. V. “Rapid liquid-chromatographic separation of steroids on columns heavily loaded with stationary phase”. Clin. Chem. 17 (8): 757–64, 1971.
9. Giddings, J. Calvin, Dynamics of Chromatography, Part I. Principles and Theory. Marcel Dekker, Inc., New York. p. 281, 1965.
10. Ettre, C., “Milestones in Chromatography: The Birth of Partition Chromatography” (PDF). LCGC, Volume: 19 (5), Pg no: 506–512, 2016, and 2001.
11. Martin, A J P; Synge, R L M, “Separation of the higher monoamino-acids by counter-current liquid-liquid extraction: the amino-acid composition of wool”. Biochemical Journal. Volume: 35 (1–2), Pg no: 91–121, 1941.
12. Lindsay, S.; Kealey, D., High performance liquid chromatography. Wiley. from review Hung, L. B.; Parcher, J. F.; Shores, J. C.; Ward, E. H. (1988). “Theoretical and experimental foundation for surface-coverage programming in gas–solid chromatography with an adsorbable carrier gas”. J. Am. Chem. Soc. Volume: 110(11), Pg no: 1090–1096, 1987.
13. Journal of Pharmaceutical and Biomedical Analysis Volume 21, Issue 2, Pages 371–382, 1 November 1999.
14. Tropical Journal of Pharmaceutical Research, © Pharmacotherapy Group, Volume: 8(5), Pg no: 449-454, October 2009.
15. Rabi Sankar, Instrumental Method of Analysis, P-18-6, P-18-3.
16. Lloyd R. Snyder, Practical HPLC Method Development, 2nd edition, P-503.
17. Guidance for industry, Analytical Procedure and Method Validation, U.S. Department of Health and Human Services FDA, August 2000.
18. Validation of analytical procedures, methodology, ICH harmonized tripartite guideline, 108, 1996.
19. B.K. Sharma, Instrumental Methods of Chemical Analysis, pp.75-78, 113-115.
20. Galen W. Ewing, Instrumental Methods of Chemical Analysis, Vth Ed., 1.
21. Takeru Higuchi, Einar Brochmann, Hanffen Hanssen, Pharmaceutical Analysis, 1st edition, 1-10.
22. A.H. Beckett, J.B. Stenlake, Practical Pharmaceutical Chemistry, IV edition, Volume II, Pg no: 275-298.
23. Quality Assurance, worth the effort, Inforum, volume 7; number.4, October 2003.
24. P.D. Sethi, Quantitative Analysis of drugs in Pharmaceutical formulation, IIIrd Ed., pp.1-21, 51-56.
25. Text on Validation of Analytical Procedures, ICH Harmonized Tripartite Guidelines, 1994.
26. Validation of Analytical Procedures: Methodology. ICH-Guidelines Q2B, Geneva. 1996, 11. (CPMP/ICH/281/95).
27. 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.
28. A Review: HPLC Method Development and Validation, Santosh Kumar Bhardwaj *et al. International Journal of Analytical and Bioanalytical Chemistry, accepted 20 November 2015.
29. Method Development: A Guide to Basics Quantitative & Qualitative HPLC, LC, GC Chromacademy.
30. 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.
31. ICH Topic Q 2 (R1) Validation of Analytical Procedures: Text and Methodology.
32. Dr. Osman Ahmed*1, Khadeeja1 and Dr. Anas Rasheed2, Evaluation and Validation of a Uplc Method For the Stability Indicating Assay of Midostaurin In Bulk Dosage Form, World Journal of Pharmaceutical and Life Sciences, WJPLS, wjpls, 2024, Vol. 10, Issue 1, 111-118.
33. Abrar Ahmed 1*, Tayyaba Mahtab2, and Sumaiyya Saleem3, Development and Validation of Midostaurin Assay by RP-HPLC Method, International Journal of Pharmaceutical Sciences and Nanotechnology, Volume 11 • Issue 6 • November – December 2018, Pages: 4318-4322.
34. Sayali Thakekar* 1, Bharti Fegade1, Madhuri Jadhav2, Dr. Vijaya Kumar Munipalli2, Dr. Raman Mohan Singh2 and Dr. Vaidhun Bhaskar1, Development and Validation of Reverse Phase High Performance Liquid Chromatographic Method For Quantitative Estimation of Midostaurin In Capsule Dosage Form, World Journal of Pharmaceutical Research, Volume 10, Issue 12, 2135-2145.
35. Narayanaswamy Harikrishnan, Gejalakshmi Subramanian, C N Hemalatha, Pavankumar V, RP-HPLC Method Development and Validation for the Estimation of Midostaurin in Bulk and Pharmaceutical Dosage Form, September 2020, International Journal of Research in Pharmaceutical Sciences 11(4):5108-5112, DOI:10.26452/ijrps.v11i4.3114.