Journal: Journal of Pharmacy Research

Article Id: JPRS-PC-00001106
Title: Application of Quality by Design in the Synthesis of 6-substituted-2-aminobenzothiazole
Category: Pharmaceutical Chemistry
Section: Research Article
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    Background: 6-chloro-2-aminobenzothiazole is a key starting material for synthesis of many APIs. Literature reveals that synthesis of 6-chloro-2-aminobenzthiozole requires more time while giving poor yield. Therefore the purpose of this study was to achieve better yield & purity by application of QbD approach. Methods: The reaction was studied for effect of temperature and effect of light during the bromination and cyclization step. Each of the focus areas and process parameters were assessed for the likely risk they pose to the quality and yield (the CQAs) of the final product, 6-chloro-2-aminobenzothiazole. The reaction was optimized using Design of Experiment. Temperature and intensity of light were selected as the independent variables. The effect of the independent variables on the % yield, % purity and reaction time was studied. Results: The design space was developed between CPPs and CQAs of the focus area, i.e., Bromination, to facilitate the process of predicting the extent of effects of CPPs over CQAs. After a good understanding of the reaction mechanism, experimental and statistical evaluation of the results, it was found that temperature shows a significant effect on all the three CQAs whereas reaction time was governed by both temperature and intensity of light. Conclusion: The reaction was optimized using graphical and numerical evaluations and was found to best fit in terms of a reaction carried out in ice bath at 0oC and a 100W bulb. More scope for improvement was found in terms of application of DoE to the Recrystallization step.

    Cite this article as: Chandrakant Bonde, Deepti Vedala, Smita Bonde,Application of Quality by Design in the Synthesis of 6-substituted-2-aminobenzothiazole,Journal of Pharmacy Research 2015,9(9),573-580

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    Author(s) Name:

    Chandrakant Bonde* Deepti Vedala, Smita Bonde

    Affiliation(s) Name:

    School of Pharmacy & Technology Management, SVKM’s NMIMS, Shirpur- 425405,Dist. Dhule, Maharashtra (India)

    *Corresponding author.
    Dr. Smita Bonde
    School of Pharmacy & Technology Management,
    Mumbai Agra Road, Bank of Tapi River,
    Savalde, Shirpur-425405, Dist Dhule,
    Maharashtra, India

    Received on:20-07-2015; Revised on: 23-08-2015; Accepted on: 28-09-2015

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    Chandrakant Bonde* Deepti Vedala, Smita Bonde

    Title:Application of Quality by Design in the Synthesis of 6-substituted-2-aminobenzothiazole
    Journal:Journal of Pharmacy Research
    Vol(issue):9 (September)
    Page No: (573-580)
  • Experimental Methods Keywords

    Methodology:Bromination and cyclization step
    Research Materials:6-substituted-2-aminobenzothiazole


6-chloro-2-aminobenzothiazole Bromine QbD temperature intensity of light

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