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GC-HS Method for Organic Volatile Impurities Determination and Quantification in Sertraline HCl API and Its Pharmaceutical Dosage Forms
Asian Journal of Chemistry,
Vol. 30 No. 8 (2018): Vol 30 Issue 8
Abstract
In this work, a simple and sensitive GC-HS method for simultaneous determination of organic volatile impurities (methanol and ethyl acetate) in sertraline HCl API and its pharmaceutical dosage forms by GC-HS with FID. Based on good manufacturing practices, measuring organic volatile impurities are mandatory for the testing of all API’s. In order to remove the potential toxic risk of residual solvents, an efficient and sensitive GC-HS method was successfully developed and validated. The method involved a thermal gradient elution of organic volatile impurities present in sertraline HCl API. DB-624, 30 m × 0.53 mm × 3.0 μm column using nitrogen as a carrier gas. The flow rate was 3 mL/min and FID was used. And the detector temperature is 250 ºC and injector temperature is 225 ºC. The total run time is 25 min. This method was validated for repeatability, method precession, linearity, limit of detection, limit of quantification, tablet analysis, solution stability and accuracy according to ICH guidelines.
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- M.M. Khater, Y.M. Issa, H.B. Hassib and S.H. Mohammed, J. Adv. Res., 6, 459 (2015); https://doi.org/10.1016/j.jare.2014.11.005.
- F. Bonadio, P. Margot, O. Delémont and P. Esseiva, Forensic Sci. Int., 187, 73 (2009); https://doi.org/10.1016/j.forsciint.2009.03.004.
- J. Li, S. Shao, M. Solorzano, G.J. Allmaier and P.T. Kurtulik, J. Chromatogr. A, 1216, 3328 (2009); https://doi.org/10.1016/j.chroma.2009.02.029.
- R. Barro, J. Regueiro, M. Llompart and C. Garcia-Jares, J. Chromatogr. A, 1216, 540 (2009); https://doi.org/10.1016/j.chroma.2008.10.117.
- V. Pinnel, P. Rosseels and J. Vandegans, J. High Resolut. Chromatogr., 18, 776 (1995); https://doi.org/10.1002/jhrc.1240181212.
- ICH Harmonized Tripartite Guidelines for Residual Solvents. Step 4, 17 July (1997).
- K. Fliszar, J.M. Wiggins, C.M. Pignoli, G.P. Martin and Z. Li, J. Chromatogr. A, 1027, 83 (2004); https://doi.org/10.1016/j.chroma.2003.08.086.
- ICH, Guidelines Q2B Validation of Analytical Procedures Methodology, In: Proceedings of I.C.H. Public Meeting, Rockville, USA, pp. 1-10 (1996).
References
M.M. Khater, Y.M. Issa, H.B. Hassib and S.H. Mohammed, J. Adv. Res., 6, 459 (2015); https://doi.org/10.1016/j.jare.2014.11.005.
F. Bonadio, P. Margot, O. Delémont and P. Esseiva, Forensic Sci. Int., 187, 73 (2009); https://doi.org/10.1016/j.forsciint.2009.03.004.
J. Li, S. Shao, M. Solorzano, G.J. Allmaier and P.T. Kurtulik, J. Chromatogr. A, 1216, 3328 (2009); https://doi.org/10.1016/j.chroma.2009.02.029.
R. Barro, J. Regueiro, M. Llompart and C. Garcia-Jares, J. Chromatogr. A, 1216, 540 (2009); https://doi.org/10.1016/j.chroma.2008.10.117.
V. Pinnel, P. Rosseels and J. Vandegans, J. High Resolut. Chromatogr., 18, 776 (1995); https://doi.org/10.1002/jhrc.1240181212.
ICH Harmonized Tripartite Guidelines for Residual Solvents. Step 4, 17 July (1997).
K. Fliszar, J.M. Wiggins, C.M. Pignoli, G.P. Martin and Z. Li, J. Chromatogr. A, 1027, 83 (2004); https://doi.org/10.1016/j.chroma.2003.08.086.
ICH, Guidelines Q2B Validation of Analytical Procedures Methodology, In: Proceedings of I.C.H. Public Meeting, Rockville, USA, pp. 1-10 (1996).