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Stability Indicating RP-HPLC Method Development and Validation for Dexamethasone
Corresponding Author(s) : C.H. Gill
Asian Journal of Chemistry,
Vol. 32 No. 3 (2020): Vol 32 Issue 3
Abstract
A new, simple, reliable and reproducible stability indicating RP-HPLC assay method has been developed for quantitative analysis of dexamethasone from dexamethasone tablets. This developed method has been validated according to ICH guideline with respect to system suitability, specificity, precision, linearity, accuracy and robustness. An isocratic condition of mobile phase water (0.1% orthophosphoric acid):acetonitrile in a ratio of 60:40, v/v at a flow rate of 1.0 mL/minute over RP 2.5 Fortis C18, 100 × 4.6 mm, 2.5 μm, column was at 27 ºC maintained. This method is specific and showed excellent linear response with correlation coefficient (R2) values of 0.999. In forced degradation, the proposed method has been investigated with different stress conditions as hydrolytic, oxidative, thermal and humid as recommended by ICH guidelines. An accurate and reliable reversed-phase HPLC method for the analysis of dexamethasone in dexamethasone tablets was developed and validated successfully.
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- A.M. Watts, A.W. Cripps, N.P. West and A.J. Cox, Front. Pharmacol., 10, 294 (2019); https://doi.org/10.3389/fphar.2019.00294
- C.H. Gill, P.N. Kulkarni, A.S. Nipate, C.K. Jadhav, A.V. Chate and A.M. Dodake-Supekar, J. Drug Deliv. Ther., 8(6-s), 236 (2018); https://doi.org/10.22270/jddt.v8i6-s.2222
- C.A.C. Jessurun, A.F.C. Hulsbergen, L.D. Cho, L.S. Aglio, R.D.S.N. Tewarie and M.L.D. Broekman, J. Neurooncol., 144. 249 (2019); https://doi.org/10.1007/s11060-019-03238-4
- S. Shaikh, H. Verma, N. Yadav, M. Jauhari and J. Bullangowda, ISRN Anesthesiol., 2012, Article ID 985495 (2012); https://doi.org/10.5402/2012/985495
- Dexamethasone USP monograph, USP29-NF24-Page 643; http://ftp.uspbpep.com/v29240/usp29nf24s0_m23280.html
- T. Thamaraikani, S. Mounika and S. Vijith, Int. Res. J. Pharm. App. Sci., 2, 5 (2012).
- International Conference on Harmonization ICH guidelines, Q6A, Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (2000); https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-6-test-procedures-acceptance-criteria-new-drug-substances-new-drugproducts-chemical_en.pdf
- G.M.S. Gonçalves and P.M.B.G.M. Campos, Braz. J. Pharm. Sci., 45, 1 (2009); https://doi.org/10.1590/S1984-82502009000100002
- International Conference on Harmonization ICH-Q2 (R1), Guideline on Validation of Analytical Procedure: Text and Methodology (2005).
- International Conference on Harmonization ICH guidelines, Q1A (R2): Stability Testing of New Drug Substances and Products (revision2) (2003).
- H. Brummer, Life Sci. Technol. Bull., 31, 1 (2011).
- R. Maheshwaran, Pharm. Technol., 36, 73 (2012).
- European Pharmacopeia 7.0, European Directorate of Quality Medicines (2011).
- M. Blessy, R.D. Patel, P.N. Prajapati and Y.K. Agrawal, J. Pharm. Anal., 4, 159 (2014); https://doi.org/10.1016/j.jpha.2013.09.003
References
A.M. Watts, A.W. Cripps, N.P. West and A.J. Cox, Front. Pharmacol., 10, 294 (2019); https://doi.org/10.3389/fphar.2019.00294
C.H. Gill, P.N. Kulkarni, A.S. Nipate, C.K. Jadhav, A.V. Chate and A.M. Dodake-Supekar, J. Drug Deliv. Ther., 8(6-s), 236 (2018); https://doi.org/10.22270/jddt.v8i6-s.2222
C.A.C. Jessurun, A.F.C. Hulsbergen, L.D. Cho, L.S. Aglio, R.D.S.N. Tewarie and M.L.D. Broekman, J. Neurooncol., 144. 249 (2019); https://doi.org/10.1007/s11060-019-03238-4
S. Shaikh, H. Verma, N. Yadav, M. Jauhari and J. Bullangowda, ISRN Anesthesiol., 2012, Article ID 985495 (2012); https://doi.org/10.5402/2012/985495
Dexamethasone USP monograph, USP29-NF24-Page 643; http://ftp.uspbpep.com/v29240/usp29nf24s0_m23280.html
T. Thamaraikani, S. Mounika and S. Vijith, Int. Res. J. Pharm. App. Sci., 2, 5 (2012).
International Conference on Harmonization ICH guidelines, Q6A, Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (2000); https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-6-test-procedures-acceptance-criteria-new-drug-substances-new-drugproducts-chemical_en.pdf
G.M.S. Gonçalves and P.M.B.G.M. Campos, Braz. J. Pharm. Sci., 45, 1 (2009); https://doi.org/10.1590/S1984-82502009000100002
International Conference on Harmonization ICH-Q2 (R1), Guideline on Validation of Analytical Procedure: Text and Methodology (2005).
International Conference on Harmonization ICH guidelines, Q1A (R2): Stability Testing of New Drug Substances and Products (revision2) (2003).
H. Brummer, Life Sci. Technol. Bull., 31, 1 (2011).
R. Maheshwaran, Pharm. Technol., 36, 73 (2012).
European Pharmacopeia 7.0, European Directorate of Quality Medicines (2011).
M. Blessy, R.D. Patel, P.N. Prajapati and Y.K. Agrawal, J. Pharm. Anal., 4, 159 (2014); https://doi.org/10.1016/j.jpha.2013.09.003