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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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| Authors: | Khan Muzaffar Kumar Shyam Jayasree K. Krishna Reddy K. V. S. R. Dubey P. K. |
| Affiliation: | 1.Regulatory Affairs, Laurus Labs Private Limited, ICICI Knowledge Park, Turkapally, Shameerpet, Hyderabad, 500078, India ;2.Analytical Development, Laurus Labs Private Limited, ICICI Knowledge Park, Turkapally, Shameerpet, Hyderabad, 500078, India ;3.Department of Chemistry, Jawaharlal Nehru Technological University, Kukatpally, Hyderabad, 500072, India ; |
| 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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