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Investigation on Impurity Profiling and Degradation Behavior of WCK 771

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Abstract

WCK 771 is a novel antibacterial drug recently launched in India for the treatment of acute bacterial skin and skin structure infections (ABSSSI). This report describes identification, quantification of impurities and degradation products (DPs) in the drug substance. The research embraces development of two reversed phase liquid chromatographic (RP-LC) methods; one mass spectrometer (MS) compatible method for identification and another UV detection method for the quantification of impurities. Four process impurities and eight DPs were identified using liquid chromatography tandem mass spectrometry (LC–MS/MS). The chromatographic separation was achieved on C18 column applying gradient elution. WCK 771 was subjected to hydrolytic, oxidative, photolytic and thermal stress. Degradation was observed only in acidic and oxidative environment. Validated UV method is accurate and precise to quantify impurities with accuracy greater than 98.71% and precision of less than 2.82%. The method is highly sensitive to detect impurities as low as 0.17 ng on column. The developed method is employed for quality control and stability studies of the new drug substance.

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Acknowledgements

The authors acknowledge the discussions with Dr. Vijay Chavan and Dr. Yasinalli Tamboli in predicting the structures of degradation products.

Funding

The research work presented in this manuscript is a part of drug discovery research program of Wockhardt Limited.

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Authors and Affiliations

  1. Wockhardt Research Centre, D-4, MIDC, Chikalthana, Aurangabad, 431006, India

    Vipul P. Rane, Rushikesh H. Patil, Kiran R. Patil, Amin R. Pathan, Sukantakumar Naik, Vinod K. Ahirrao, Rajiv A. Jadhav & Ravindra D. Yeole

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  1. Vipul P. Rane
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  2. Rushikesh H. Patil
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  3. Kiran R. Patil
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  4. Amin R. Pathan
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  5. Sukantakumar Naik
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  6. Vinod K. Ahirrao
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  7. Rajiv A. Jadhav
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  8. Ravindra D. Yeole
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Contributions

VPR: UV based LC method development and drafting the manuscript. RP: conducted forced degradation studies. KP: MS compatible LC method development. AP: LC–MS analysis. SN: LC–MS/MS analysis. VKA: Review of method validation data and editing of manuscript. RJ: Application of LC method for analysis of batches. RDY: Project administration, planning of experiments, interpretation of data, review and editing of manuscript.

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Correspondence to Vipul P. Rane.

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The presented work is original research work of Wockhardt Limited and all the authors are employees of Wockhardt Limited.

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Rane, V.P., Patil, R.H., Patil, K.R. et al. Investigation on Impurity Profiling and Degradation Behavior of WCK 771. Chromatographia 85, 155–165 (2022). https://doi.org/10.1007/s10337-021-04122-y

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  • DOI: https://doi.org/10.1007/s10337-021-04122-y

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