Validated HPLC Method for Determination of Contents of Residual Aminoguanidine in Drug Substances

This paper describes a validated method for the quantification of aminoguanidine in drug substances and their intermediates using High Performance Liquid Chromatography (HPLC), with a per column derivatization with 1-Naphthyl isothiocyanate. Derivative formed was analysed using a RP-18 HPLC column with pH 3 ortho-phosphoric acid and triethyleamine buffer and Methanol as mobile phase with a gradient elution. Wavelength 220 nm was used for detection. The method is validated for its Specificity, Precision, Accuracy, Linearity Ruggedness and Robustness. Aminoguanidine is linear from 0.015μg/ml to 0.750 μg/ml with correlation coefficient 0.99609. Limit of Quantitation of the method is 0.015 μg/ml and Limit of Detection is 0.010 μg/ml.