Authors:
Pankaj B. Miniyar Sinhgad Technical Education Society's Sinhgad Institute of Pharmacy, Narhe, Pune 411041, India

Search for other papers by Pankaj B. Miniyar in
Current site
Google Scholar
PubMed
Close
,
Resham D. Kulkarni Sinhgad Technical Education Society's Sinhgad Institute of Pharmacy, Narhe, Pune 411041, India

Search for other papers by Resham D. Kulkarni in
Current site
Google Scholar
PubMed
Close
,
Asha B. Thomas Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research Pimpri, Pune 411018, India

Search for other papers by Asha B. Thomas in
Current site
Google Scholar
PubMed
Close
, and
Sohan S. Chitlange Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research Pimpri, Pune 411018, India

Search for other papers by Sohan S. Chitlange in
Current site
Google Scholar
PubMed
Close
Restricted access

Summary

Genotoxic impurities can be described as impurities that can induce genetic mutations and chromosomal breaks, or that damage the genetic information within a cell, which may lead to cancer. The European Medical Agency (EMA) and the United States Food and Drug Administration (US FDA) have set a threshold of toxicological concern (TTC) of genotoxic impurities 1.5 µg per day. In a continuous effort to develop an analytical method for the estimation of genotoxic impurities in quetiapine fumarate, a sensitive, simple, and precise high-performance thin-layer chromatography method has been developed and validated for the determination of 2-nitrophenyl (phenyl)sulfane as a genotoxic impurity at trace levels. The limits of detection (LOD) for quetiapine fumarate and 2-nitrophenyl (phenyl)sulfane were found to be 5.11 and 15.5 ng per band, whereas the limits of quantification (LOQ) were observed 0.09 and 0.3 ng per band, respectively. The calibration curve for 2-nitrophenyl (phenyl)sulfane was linear over the concentration range of 10 to 50 ng per band. The method was found to be specific, precise, linear, and accurate for the estimation of 2-nitrophenyl (phenyl)sulfane at trace levels in quetiapine fumarate.

  • [1]

    International Conference on Harmonization (ICH), Guideline Q3B (R2): Impurities in New Drug Products, Geneva, October 2006.

  • [2]

    International Conference on Harmonization (ICH), Guideline Q3A (R2): Impurities in New Drug Substances, Geneva, October 2006.

  • [3]

    European Medicines Agency (EMEA), Committee for Medicinal Products for Human Use (CHMP), Guidelines on the limits of genotoxic impurities, London, June 2006.

    • Search Google Scholar
    • Export Citation
  • [4]

    M7 (R1) Assessment and control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk ; US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Silver Spring, MD, March 2018.

    • Search Google Scholar
    • Export Citation
  • [5]

    R. Parajuli , P. Pokhrel, M. Bhattarai, B. Shrestha, Impurity profiling: an emerging approach for pharmaceuticals, World J. Pharm. Sci. 7 (2018) 16701683.

    • Search Google Scholar
    • Export Citation
  • [6]

    T. McGovern , D. Jacobson-Kram, Regulation of genotoxic and carcinogenic impurities in drug substances and products, Trends Anal. Chem. 25 (2006) 790795.

    • Search Google Scholar
    • Export Citation
  • [7]

    A. Vijaya Bhaskar , N. Reddy, G. Venugopal, G. Reddy, V. Madhavi, A selective and sensitive UPLC-MS/MS approach for trace level quantification of four potential genotoxic impurities in zolmitriptan drug substance, J. Pharm. Biomed Anal. 84 (2013) 8489.

    • Search Google Scholar
    • Export Citation
  • [8]

    D. Liu , M. Sun, A. Kord, Recent advances in trace analysis of pharmaceutical genotoxic impurities, J. Pharm. Biomed. Anal. 51 (2010) 9991014.

    • Search Google Scholar
    • Export Citation
  • [9]

    D. Snodin , Genotoxic impurities: a regulatory toxicology commentary on recent articles in organic process research and development, Org. Process Res. Dev. 15 (2011) 12431246.

    • Search Google Scholar
    • Export Citation
  • [10]

    E. Stolarczyk , L. Kaczmarek, K. Eksanow, M. Kubiszewski, M. Glice, A. Kuther, Identification and characterization of potential impurities of quetiapine fumarate, Pharm. Dev. Technol. 14 (2009) 2939.

    • Search Google Scholar
    • Export Citation
  • [11]

    R. Valarmathi , S. Akilandeswari, D. Dhharshini, S. Farishabanu, R. Senthamarai, Atypical antipsychotic drug - quetiapine fumarate and its analytical techniques, Int. J. Pharm. Chem. Sci. 2 (2013) 197206.

    • Search Google Scholar
    • Export Citation
  • [12]

    Z. Cimarosti , F. Bravo, P. Stonestreet, F. Tinazzi, O. Vecchi, G. Camurri, Application of quality by design principles to support development of a control strategy for the control of genotoxic impurities in the manufacturing process of a drug substance, Org. Process Res. Dev. 14 (2010) 993998.

    • Search Google Scholar
    • Export Citation
  • [13]

    S. Raillard , J. Bercu, S. Baertschi, C. Riley, Prediction of drug degradation pathways leading to structural alerts for potential genotoxic impurities, Org. Process Res. Dev. 14 (2010) 10151020.

    • Search Google Scholar
    • Export Citation
  • [14]

    R. Nagaraju , B. Kanakapura, V. Kanakapura, Extractive spectrophotometric determination of quetiapine fumarate in pharmaceuticals and spiked human urine, Croat. Chem. Acta 85 (2012) 917.

    • Search Google Scholar
    • Export Citation
  • [15]

    K. Vinay , H. Revanasidappa, Spectrophotometric determination of quetiapine fumarate in pharmaceuticals and human urine by two charge-transfer complexation reactions, Chem. Ind. Chem. Engg. 18 (2012) 263272.

    • Search Google Scholar
    • Export Citation
  • [16]

    K. Vinay , H. Revanasidappa, N. Rajendraprasad, Potentiometeric determination of quetiapine fumarate in pharmaceutical formulations, Port. Electrochim. Acta 28 (2010) 299308.

    • Search Google Scholar
    • Export Citation
  • [17]

    N. Kumar , D. Sangeetha, R. Goyal, P. Reddy, A validated stability indicating RP-LC method for the estimation of process related impurities and degradation products of quetiapine fumarate in solid dosage form, Acta Chromatogr. 25 (2013) 393409.

    • Search Google Scholar
    • Export Citation
  • [18]

    S. Hillaert , L. Snoeck, W. Van den Bossche, Optimization and validation of a capillary zone electrophoretic method for the simultaneous analysis of four atypical antipsychotics, J. Chromatogr. A 1033 (2004) 357362.

    • Search Google Scholar
    • Export Citation
  • [19]

    K. Venkata , S. Battula, S. Dubey, Validation of quetiapine fumarate in pharmaceutical dosage by reverse-phase HPLC with internal standard method, J. Chem. 2013 (2013) Article ID 578537, 18.

    • Search Google Scholar
    • Export Citation
  • [20]

    M. Mannam , S. Sankareswaran, V. Reddy, S. Natarajan, R. Kottapalli, P. Kumar, Structural correction and process improvement for control of critical process impurity of ezetimibe, Org. Process Res. Dev. 23 (2019) 116.

    • Search Google Scholar
    • Export Citation
  • [21]

    M. Mahadik , N. Patare, S. Dhaneshwar, Stability-indicating HPTLC method for quantitation of quetiapine fumarate in the pharmaceutical dosage form, Acta Chromatogr. 21 (2009) 8393.

    • Search Google Scholar
    • Export Citation
  • [22]

    Z. Dendania , N. Sheth, R. Dendania, Stability indicating high performance thin layer chromatographic determination of quetiapine fumarate, Int. J. Pharm. Sci. Res. 4 (2013) 24062414.

    • Search Google Scholar
    • Export Citation
  • [23]

    R. Sathiya , K. Krishnaraj, S. Muralidharan, N. Muruganantham, A simple and validated HPTLC method of evaluation for quetiapine fumarate in oral solid dosage form, Eurasian J. Anal. Chem. 5 (2010) 246253.

    • Search Google Scholar
    • Export Citation
  • [24]

    Y. Huang , H. Lu, F. Zhang, C. Min, Identification, isolation, characterization, and UPLC quantification of potential genotoxic impurities in linagliptin, J. Sep. Sci. 41 (2018) 133.

    • Search Google Scholar
    • Export Citation
  • [25]

    A. Baldwin , R. North, S. Eisenbeis, Trace level quantification of derivatized boronic acids by LC-MS/MS, Org. Process Res. Dev. 23 (2019) 8892.

    • Search Google Scholar
    • Export Citation
  • [26]

    S. Gudlawar , J. Dwivedi, N. Venugopal, A selective and sensitive UPLC-MS/MS method for simultaneous determination of four genotoxic impurities in levofloxacin, Rasayan J. Chem. 8 (2015) 4755.

    • Search Google Scholar
    • Export Citation
  • Collapse
  • Expand

To see the editorial board, please visit the website of Springer Nature.

Manuscript Submission: HERE

For subscription options, please visit the website of Springer Nature.

Journal of Planar Chromatography - Modern TLC
Language English
Size A4
Year of
Foundation
1988
Volumes
per Year
1
Issues
per Year
6
Founder Akadémiai Kiadó
Founder's
Address
H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
Publisher Akadémiai Kiadó
Springer Nature Switzerland AG
Publisher's
Address
H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
CH-6330 Cham, Switzerland Gewerbestrasse 11.
Responsible
Publisher
Chief Executive Officer, Akadémiai Kiadó
ISSN 0933-4173 (Print)
ISSN 1789-0993 (Online)

Monthly Content Usage

Abstract Views Full Text Views PDF Downloads
Feb 2024 46 1 1
Mar 2024 47 1 0
Apr 2024 27 0 0
May 2024 10 0 0
Jun 2024 14 0 0
Jul 2024 7 0 0
Aug 2024 0 0 0