Abstract
A rapid, sensitive and highly selective High performance liquid chromatography (HPLC) method was developed and validated for the determination of trace level Genotoxic Melamine impurity, as required by USFDA and that may be present in Allopurinol. HPLC column used was Cosmosil C18 (250 x 4.6 mm, 5µm). The isocratic elution modewas selected where the mobile phaseconsists of 1.25 g/l Sodium dihydrogen phosphate solution. The flow rate was set to1.0 mL/minand run time of 30 minutes. UV detector with wavelength 208 nm was used for theanalysis. The column oven temperature was kept at 25°C. The developed method was validated according to ICH guideline and found to be linear in the range of 5.20 ppm to 52.05 ppm with a correlation coefficient 0.9997. Limit of detection and limit of quantitation was found to be 1.21 ppm and 3.68 ppm respectively. Recovery for this impurity was found between 93.37% and 107.59%.A method was found to be specific, selective, precise, and robust. The developed method can successfully be applied for the determination of Genotoxic Melamine impurity in Allopurinol.
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