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A Stability-Indicating LC Assay Method for Bicalutamide

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Abstract

A stability-indicating HPLC method for the quantitative determination of Bicalutamide is described. Bicalutamide is a nonsteroidal antiandrogen and is an oral medication that is used for treating prostate cancer. Separation was achieved on a Waters Symmetry shield RP18 HPLC column using a mobile phase consists of a mixture of phosphate buffer (Solvent A) and organic modifier acetonitrile (Solvent B). Degradation studies were performed on bulk samples of bicalutamide using acid (0.5 N methanolic hydrochloric acid), base (0.5 N methanolic sodium hydroxide), oxidation (10% v/v methanolic hydrogen peroxide), heat (60 °C) and UV light (254 nm). Degradation was observed under base hydrolysis to give the starting material used during the synthesis of bicalutamide. The degraded samples were assayed and gave a mass balance greater than 99.5%, thus proving the stability-indicating power of the developed method. The method was validated with respect to linearity, accuracy, precision and robustness.

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Acknowledgments

The authors wish to thank the management of Dr. Reddy’s group for supporting this work. The authors wish to acknowledge the Process Research Group for providing the samples. We would also like to thank colleagues in the Separation Science Division of Analytical Research of High Potent Active Pharmaceutical Ingredients for their co-operation in carrying out this work.

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Authors and Affiliations

  1. Analytical Research, High Potent Active Pharmaceutical Ingredients Operations, Dr. Reddy’s Laboratories, Hyderabad, 500072, India

    G. Saravanan, M. Ravikumar & M. V. Suryanarayana

  2. Analytical Research, Custom Pharmaceutical Services, Dr. Reddy’s Laboratories, Hyderabad, 500049, India

    B. M. Rao

  3. Department of Inorganic and Analytical Chemistry, Andhra University, Visakhapattanam, 530003, India

    N. Someswararao

  4. Process Research, High Potent Active Pharmaceutical Ingredients Operations, Dr. Reddy’s Laboratories, Hyderabad, 500072, India

    P. V. R. Acharyulu

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  1. G. Saravanan
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  2. B. M. Rao
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  3. M. Ravikumar
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  4. M. V. Suryanarayana
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  5. N. Someswararao
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  6. P. V. R. Acharyulu
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Corresponding author

Correspondence to B. M. Rao.

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Saravanan, G., Rao, B.M., Ravikumar, M. et al. A Stability-Indicating LC Assay Method for Bicalutamide. Chroma 66, 219–222 (2007). https://doi.org/10.1365/s10337-007-0280-0

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  • DOI: https://doi.org/10.1365/s10337-007-0280-0

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