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HPLC Method for Determining Esomeprazole and its Related Substances in Pharmaceutical Formulations
Corresponding Author(s) : T.S.S. Jagan Mohan
Asian Journal of Chemistry,
Vol. 29 No. 6 (2017): Vol 29 Issue 6
Abstract
A green, novel, selective, rapid, precise, accurate and simple isocratic reverse phase stability indicating RP-HPLC method has been developed and validated as per ICH guidelines for estimation of esomeprazole and its impurities in pharmaceutical formulations. Inertsil ODS (150 × 4.6 mm, 5 μ) stationary phase by using mobile phase 0.05 % glacial acetic acid and isopropanol in the ratio of 85:15 v/v at flow rate of 1.0 mL/min and column temperature of 50 °C. Esomeprazole was detected at 280 nm. The proposed method was validated as per ICH guidelines for precision, accuracy, specificity, robustness and sensitivity. The proposed method proves its stability by resolving esomeprazole peak from its degradation products in forced degradation study. The proposed method is not only eco-friendly but faster than the official method in EP 8.0 by meeting resolution criteria as per the monograph. The proposed method was capable to determine assay of esomeprazole in the presence of its related substances within the same run. The proposed method can be used for routine analysis in quality control laboratories for its pharmaceutical formulations.
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- R.K. Gilpin and C.S. Gilkin, Anal. Chem., 79, 4275 (2007); https://doi.org/10.1021/ac070708x.
- International Conference of Harmonisation-ICH, Impurities: Guideline for Residual Solvents Q3C (R5), Harmonised Tripartite Guideline (2011).
- A.B. Eldin, A. Shalaby, M.S. Abdallah, M.A. Shaldam, M.A. Abdallah, Arabian J. Chem.; https://doi.org/10.1016/j.arabjc.2014.10.051.
- S. Armenta, S. Garrigues and M. de la Guardia, Green Anal. Chem. Trends Anal. Chem., 27, 497 (2008); https://doi.org/10.1016/j.trac.2008.05.003.
- C.J. Welch, T. Brkovic, W. Schafer and X. Gong, Green Chem., 11, 1232 (2009); https://doi.org/10.1039/b906215g.
- M. Tonini, S. Vigneri, V. Savarino and C. Scarpignato, Dig. Liver Dis., 33, 600 (2001); https://doi.org/10.1016/S1590-8658(01)80115-8.
- P.B. Kale-Pradhan, H.K. Landry and W.T. Sypula, Ann. Pharmacother., 36, 655 (2002); https://doi.org/10.1345/aph.1A104.
- S.U. Nalwade, V.R. Reddy, D.D. Rao and N.K. Morisetti, J. Pharm. Biomed., 57, 109 (2012); https://doi.org/10.1016/j.jpba.2011.08.025.
- Esomeprazole Magnesium Trihydrate Monograph, European Pharmacopoeia 8.0, pp. 2168–2169 (2015).
- A. Onal and A. Oztunc, J. Food Drug Anal., 14, 12 (2006).
- International Conference of Harmonisation-ICH, Validation of Analytical Procedures: Text and Methodology Q2 (R1), Harmonized Tripartite Guideline (2005).
- J.H. Clark and S.J. Tavener, Org. Process Res. Dev., 11, 149 (2007); https://doi.org/10.1021/op060160g.
References
R.K. Gilpin and C.S. Gilkin, Anal. Chem., 79, 4275 (2007); https://doi.org/10.1021/ac070708x.
International Conference of Harmonisation-ICH, Impurities: Guideline for Residual Solvents Q3C (R5), Harmonised Tripartite Guideline (2011).
A.B. Eldin, A. Shalaby, M.S. Abdallah, M.A. Shaldam, M.A. Abdallah, Arabian J. Chem.; https://doi.org/10.1016/j.arabjc.2014.10.051.
S. Armenta, S. Garrigues and M. de la Guardia, Green Anal. Chem. Trends Anal. Chem., 27, 497 (2008); https://doi.org/10.1016/j.trac.2008.05.003.
C.J. Welch, T. Brkovic, W. Schafer and X. Gong, Green Chem., 11, 1232 (2009); https://doi.org/10.1039/b906215g.
M. Tonini, S. Vigneri, V. Savarino and C. Scarpignato, Dig. Liver Dis., 33, 600 (2001); https://doi.org/10.1016/S1590-8658(01)80115-8.
P.B. Kale-Pradhan, H.K. Landry and W.T. Sypula, Ann. Pharmacother., 36, 655 (2002); https://doi.org/10.1345/aph.1A104.
S.U. Nalwade, V.R. Reddy, D.D. Rao and N.K. Morisetti, J. Pharm. Biomed., 57, 109 (2012); https://doi.org/10.1016/j.jpba.2011.08.025.
Esomeprazole Magnesium Trihydrate Monograph, European Pharmacopoeia 8.0, pp. 2168–2169 (2015).
A. Onal and A. Oztunc, J. Food Drug Anal., 14, 12 (2006).
International Conference of Harmonisation-ICH, Validation of Analytical Procedures: Text and Methodology Q2 (R1), Harmonized Tripartite Guideline (2005).
J.H. Clark and S.J. Tavener, Org. Process Res. Dev., 11, 149 (2007); https://doi.org/10.1021/op060160g.