Method Development and its Validation for Antineoplastic Agents (Ruxolitinib) by RP-HPLC
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 10 No. 2 (2022): 2022 Volume - 10 Issue - 2
Abstract
A sensitive& selective RP-HPLC method has been developed & validated for the analysis of Ruxolitinib. Encourage the proposed RP-HPLC technique has astounding affectability, accuracy and reproducibility. The outcome demonstrates the created technique is amazingly, one more appropriate strategy for test, immaculateness and solidness which can help in the examination of Ruxolitinib in various definitions.
Keywords
RP-HPLC, Ruxolitinib, Method development, Validation parameters
1.
N. Sai kiran, H.Parameshwar, A.V. Jithan. Method Development and its Validation for Antineoplastic Agents (Ruxolitinib) by RP-HPLC. Int. J. of Allied Med. Sci. and Clin. Res. [Internet]. 2022 Jul. 4 [cited 2026 Jan. 13];10(2):268-73. Available from: https://ijamscr.com/ijamscr/article/view/1215
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References
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1. Gerber F, Krummen M, Potgeter H, Roth A, Siffrin C, Spoendlin C. Practical aspects of fast reversed-phase high-performance liquid chromatography using 3-?m particle packed columns and monolithic columns in pharmaceutical development and production working under current good manufacturing practice. J Chromatogr A. 2004;1036(2):127-33. doi: 10.1016/j.chroma.2004.02.056, PMID 15146913.
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9. Higuchi T, EinarBrochmann HH. Pharmaceutical analysis. 1st ed. p. 1-10.
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12. Text on Validation of Analytical Procedures, ICH Harmonized Tripartite Guidelines, 1994.
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References
1. Gerber F, Krummen M, Potgeter H, Roth A, Siffrin C, Spoendlin C. Practical aspects of fast reversed-phase high-performance liquid chromatography using 3-?m particle packed columns and monolithic columns in pharmaceutical development and production working under current good manufacturing practice. J Chromatogr A. 2004;1036(2):127-33. doi: 10.1016/j.chroma.2004.02.056, PMID 15146913.
2. Karger BL, Berry LV. Rapid liquid-chromatographic separation of steroids on columns heavily loaded with stationary phase. Clin Chem. 1971;17(8):757-64. doi: 10.1093/clinchem/17.8.757, PMID 4254537.
3. Giddings J. Calvin,dynamics of chromatography, Part I. Principles and theory. New York: Marcel Dekker, Inc; 1965. p. 281.
4. Snyder LR. Practical HPLC method development. 2nd ed, P-503.
5. Guidance for industry, Analytical Procedure and Method Validation, U.S. Department of Health and Human Services FDA, August 2000.
6. Validation of analytical procedures, methodology. Ich harmonized tripartite guideline. Vol. 108; 1996.
7. Sharma BK. Instrumental methods of chemical analysis. p. 75-8, 113-5.
8. Ewing GW. Instrumental methods of chemical analysis. 5th ed. Vol. 1.
9. Higuchi T, EinarBrochmann HH. Pharmaceutical analysis. 1st ed. p. 1-10.
10. Beckett AH, Stenlake JB. Practical pharmaceutical chemistry. 4th ed. Vol. II, Pg no: 275-298.
11. Yang LP, Keating GM. Ruxolitinib: in the treatment of myelofibrosis. Drugs. November 12, 2012;72(16):2117-27.
12. Text on Validation of Analytical Procedures, ICH Harmonized Tripartite Guidelines, 1994.
13. Cervantes F, Martinez-Trillos A: Myelofibrosis: an update on current pharmacotherapy and future directions. Expert Opin Pharmacotherapy, Epub 2013 ;14(7):873-84.
2. Karger BL, Berry LV. Rapid liquid-chromatographic separation of steroids on columns heavily loaded with stationary phase. Clin Chem. 1971;17(8):757-64. doi: 10.1093/clinchem/17.8.757, PMID 4254537.
3. Giddings J. Calvin,dynamics of chromatography, Part I. Principles and theory. New York: Marcel Dekker, Inc; 1965. p. 281.
4. Snyder LR. Practical HPLC method development. 2nd ed, P-503.
5. Guidance for industry, Analytical Procedure and Method Validation, U.S. Department of Health and Human Services FDA, August 2000.
6. Validation of analytical procedures, methodology. Ich harmonized tripartite guideline. Vol. 108; 1996.
7. Sharma BK. Instrumental methods of chemical analysis. p. 75-8, 113-5.
8. Ewing GW. Instrumental methods of chemical analysis. 5th ed. Vol. 1.
9. Higuchi T, EinarBrochmann HH. Pharmaceutical analysis. 1st ed. p. 1-10.
10. Beckett AH, Stenlake JB. Practical pharmaceutical chemistry. 4th ed. Vol. II, Pg no: 275-298.
11. Yang LP, Keating GM. Ruxolitinib: in the treatment of myelofibrosis. Drugs. November 12, 2012;72(16):2117-27.
12. Text on Validation of Analytical Procedures, ICH Harmonized Tripartite Guidelines, 1994.
13. Cervantes F, Martinez-Trillos A: Myelofibrosis: an update on current pharmacotherapy and future directions. Expert Opin Pharmacotherapy, Epub 2013 ;14(7):873-84.