Method development and validation of a new stability indicating HPLC and LC-APCI-MS methods for the determination of Bumetanide

Bumetanide is a diuretic used to reduce edema caused by the conditions such as heart failure, kidney disease, and liver disease. A new stability indicating isocratic LC-APCI-MS and RP-HPLC methods have been developed and validated for the estimation of Bumetanide as per ICH guidelines. Thermo scientific-TSQ Quantis with Vanquish HPLC coupled with MS was used for the present study. Simpack C18 column was used for chromatographic resolution and a triple quadrupole mass spectrometer with atmospheric pressure chemical ionization (APCI) source, running in the positive mode (as well as negative mode) was used for detection. A mixture of 0.1% Formic acid: Acetonitrile was used as mobile phase on gradient mode and Acetonitrile was used as diluent. A wide linearity concentration range 5.0-200 μg/ml was shown by the proposed method. The proposed methods are simple, precise, accurate and used to quantify the marketed formulations of Bumetanide. Stress degradation studies were performed and the method is found to be selective and specific.