DEVELOPMENT AND VALIDATION OF RELATED SUBSTANCES METHOD BY HPLC FOR ANALYSIS OF HYDRALAZINE HYDROCHLORIDE
Ajit Anerao*, Vikram Dighe, Ravindra Pagire, Sachin Sonavane, Nitin Pradhan
ABSTRACT
Process related impurities associated with the synthesis of Hydralazine hydrochloride active pharmaceutical ingredient (API) was detected by high performance liquid chromatography (HPLC). The impurities are synthesized in laboratory and structure elucidation is done by mass spectrometry (MS), nuclear magnetic resonance spectroscopy (NMR) and infra-red spectroscopy (FTIR). Gradient HPLC method is developed for quantitation on Inertsil C18 column and validated for parameters such as specificity, accuracy, precision, linearity, robustness and ruggedness. The LOD and LOQ of all specified impurities are also determined.
Keywords: Hydralazine hydrochloride, impurity characterization, method development and validation, HPLC, FTIR, mass and NMR.
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