Quantitative Determination of Residual Hydrazine Content in Cilazapril by Ion Chromatography

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Quantitative Determination of Residual Hydrazine Content in Cilazapril by Ion Chromatography

K. Jeevana Lakshmi¹, P. Rama Devi¹* and K. Mukkanti²

¹Analytical Research and Development, Hetero Research Foundation (A division of Hetero Drugs Ltd.), B80 & 81, APIE Balanagar, Hyderabad - 500 018 (India). ²Center for Pharmaceutical Science, Institute of Science and Technology, J.N.T.University, Hyderabad - 500 072 (India).

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ABSTRACT:

A simple & economic Ion chromatographic (IC) method with conductivity detector has been developed for quantitative determination of residual hydrazine content in cilazapril. The chromatographic separation was archived on a Metro Sep C2, 150x4.6x7μm. column. The limit of detection was 1.53μg mL-1 and limit of quantification was 4.63 μg mL-1. The developed method was validated according to ICH guide lines for Accuracy, Precession and Linearity and is sensitive to detect and quantify the Hydrazine as trace element, also highly precise and accurate. The calibration curves were linear with correlation co-efficient of >0.999.

KEYWORDS:

Ion Chromatography (IC); Conductivity Detector, Cilazapril; Hydrazine; Method validation