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Original GC–FID Determination of Non-Chromophoric Impurities in Quetiapine: An Antipsychotic Drug

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Abstract

A rapid and sensitive gas chromatographic method using flame ionization detection (GC–FID) has been developed and validated for five process related non-chromophoric impurities viz, 2-(2-chloroethoxy)ethanol (2-CEE), piperazine, 2-(piperazin-1-yl)ethanol (HEP), 2-[2-(piperazin-1-yl)ethoxy]ethanol (HEEP), 2,2-[piperazine-1,4-diylbis(ethane-2,1-diyloxy)]diethanol (DEEP) observed during the process development of quetiapine hemifumarate, an antipsychotic drug is presented. All five non-chromophoric impurities ranging from 0.05 to 0.1% were detected using DB-5 (30 m × 0.53 mm, 5 μm) column with a good peak separation. The method was fully validated according to the ICH Q2 (R1) guidelines. The investigated validation protocols showed that the method has acceptable specificity, accuracy, linearity, precision, robustness and high sensitivity with detection limits and quantitation limits ranging from 0.001 to 0.01% and 0.004 to 0.03%, respectively. These non-chromophoric impurities generated during the process were identified by GC–MS and are characterized by MS, 1H NMR and FT-IR spectroscopy.

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References

  1. (a) Edward JW, Wilmington D (1989) US Pat No. 4879288, (b) http://www.astrazeneca.com/_mshost3690701/content/resources/media/investors/az-june-2008-goldmansachs.pdf, (c) http://www.news-medical.net/news/20091106/Bipolar-disorder-drug-market-to-decline-from-2463-billion-to-245-billion.aspx

  2. Campbell A, Yeghiayana S, Baladessarini RJ, Neumeyer JL (1991) Psychopharmacology 103:323–329

    Article  CAS  Google Scholar 

  3. Saller CF, Salama AI (1993) Psychopharmacology 112:285–292

    Article  CAS  Google Scholar 

  4. Goldstein JM, Litwin LC, Sutton EB, Malick JB (1993) Psychopharmacology 112:293–298

    Article  CAS  Google Scholar 

  5. Migler BM, Warawa EJ, Malick JB (1993) Psychopharmacology 112:299–307

    Article  CAS  Google Scholar 

  6. Copur M, Arpaci B, Demir T, Narin H (2007) Clin Drug Investig 27(2):30–123

    Google Scholar 

  7. Shaw JA, Lewis JE, Pascal S, Sharma RK, Rodriguez RA, Guillen R, Pupo-Guillen M (2001) J Child Adolesc Psychopharmacol 11:415–424

    Article  CAS  Google Scholar 

  8. Pullen RH, Palermo KM, Curtis MA (1992) J Chromatogr 573:49–57

    Article  CAS  Google Scholar 

  9. Kumar KV, Kanhaiya L, Suhail A, David L (2006) WO Pat appl No. 113425

  10. Fathalla Belal, Elbrashy A, Manal Eid, Nasar JJ (2008) J Liq Chromatogr Related Technol 31:1283–1298

    Article  Google Scholar 

  11. Sachse J, Koller J, Hartter S, Hiemke C (2006) J Chromatogr B 830:342–348

    Article  CAS  Google Scholar 

  12. Bharathi CH, Prabahar KJ, Prasad ChS, Rao MS, Trinadhachary GN, Handa VK, Dandala R, Naidu A (2008) Pharmazie 63:14–19

    CAS  Google Scholar 

  13. Stolarczyk EU, Kaczmarek L, Eksanow K, Kubiszewski M, Glice M, Kutner A (2009) Pharm Dev Techonol 14(1):27–37

    CAS  Google Scholar 

  14. Krishna SR, Rao BM, Rao NS (2008) Rasayan J Chem 1(3):466–474

    CAS  Google Scholar 

  15. Raju IV S, Raghuram P, Sriramulu (2009) Chromatographia 70:545–550

    Article  Google Scholar 

  16. Stolarczyk EU, Groman A, Kaczmarek LS, Golebiewski P (2007) Acta Pol Pharm 64:187–189

    CAS  Google Scholar 

  17. Niphade NC, Mali AC, Pandit BK, Jagtap KM, Jadhav SA, Jachak MN, Mathad VT (2009) Org Process Res Dev 13(4):792–797

    Article  CAS  Google Scholar 

  18. Validation of Compendial Methods. The United States Pharmacopeia (2008) 31st edn. USP 31, Section <1225>

  19. ICH, Validation of Analytical Procedures; Text and Methodology, Q2 (R1).

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Acknowledgments

The authors wish to thank the management of the Megafine group for supporting this work. We would also like to thank colleagues in the Research and Development division of Megafine Pharma (P) for their support.

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Authors and Affiliations

  1. Research and Development, Megafine Pharma (P) Ltd, 201, Lakhmpur, Dindori, Nashik, 422 202, India

    Sanjay A. Jadhav, Shashikant B. Landge, Samadhan S. Shelke, Navanath C. Niphade, Raghavendra K. Panchangam & Vijayavitthal T. Mathad

  2. Department of Chemistry, Deogiri College, Aurangabad, 431004, India

    Saroj R. Bembalkar

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  1. Sanjay A. Jadhav
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  2. Shashikant B. Landge
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  3. Samadhan S. Shelke
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  4. Navanath C. Niphade
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  5. Raghavendra K. Panchangam
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  6. Vijayavitthal T. Mathad
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  7. Saroj R. Bembalkar
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Corresponding author

Correspondence to Vijayavitthal T. Mathad.

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Jadhav, S.A., Landge, S.B., Shelke, S.S. et al. Original GC–FID Determination of Non-Chromophoric Impurities in Quetiapine: An Antipsychotic Drug. Chroma 71, 1055–1061 (2010). https://doi.org/10.1365/s10337-010-1585-y

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  • DOI: https://doi.org/10.1365/s10337-010-1585-y

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