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Simultaneous Trace Level Determination of Potentially Genotoxic Hydrazine, Methylhydrazine and Alkylamines in Pharmaceutical Substances by CE Using Indirect Photometric Detection

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Abstract

A simple, fast, and sensitive capillary electrophoretic method was developed for determining two genotoxic impurities hydrazine and methylhydrazine and eight alkyl amines at trace levels in pharmaceutical substances using indirect photometric detection. The method development involved a systematic screening of various cationic visualizing reagents and optimization of separation conditions to obtain the best resolution and sensitivities. The optimized method was validated for specificity, precision, linearity, and accuracy. Linear calibration curves (R > 0.99) were obtained for all analytes in the range LOQ–200 % of nominal concentrations. The developed CE method was effectively implemented for estimating hydrazine and alkylamines in several active pharmaceutical ingredients (APIs).

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Acknowledgments

The authors wish to thank the management of Laurus Labs Pvt. Ltd. for supporting this work. The authors also wish to acknowledge the encouragement provided by Dr. Satyanarayana C., Dr. Srihari Raju K. and Mr. Ravindra G., Laurus Labs Pvt. Ltd. throughout this work.

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Authors and Affiliations

  1. Regulatory Affairs, Laurus Labs Private Limited, ICICI Knowledge Park, Turkapally, Shameerpet, Hyderabad, 500078, India

    Muzaffar Khan

  2. Analytical Development, Laurus Labs Private Limited, ICICI Knowledge Park, Turkapally, Shameerpet, Hyderabad, 500078, India

    Shyam Kumar, K. Jayasree & K. V. S. R. Krishna Reddy

  3. Department of Chemistry, Jawaharlal Nehru Technological University, Kukatpally, Hyderabad, 500072, India

    P. K. Dubey

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  1. Muzaffar Khan
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  2. Shyam Kumar
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  3. K. Jayasree
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  4. K. V. S. R. Krishna Reddy
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  5. P. K. Dubey
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Correspondence to Muzaffar Khan.

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Khan, M., Kumar, S., Jayasree, K. et al. Simultaneous Trace Level Determination of Potentially Genotoxic Hydrazine, Methylhydrazine and Alkylamines in Pharmaceutical Substances by CE Using Indirect Photometric Detection. Chromatographia 76, 801–809 (2013). https://doi.org/10.1007/s10337-013-2467-x

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