Stability Indicating RP-HPLC Method for Bumetanide in Bulk Drug and Tablet Formulation

A simple, sensitive, selective, precise and reversed-phase stability-indicating HPLC method was developed and validated for Bumetanide (BUM) in bulk drug and in formulation. The method has shown adequate separation for BUM from their associated impurities and their degradation products. Separation was achieved on a Waters Spherisorb ODS2 C₁₈, 250 mm × 4.6 mm i.d., 5 μm column using a mobile phase consisting of methanol: water (70:30, v/v) at a flow rate of 1ml/min and UV detection at 335 nm and the retention time (T_R) was found to be 4.743 ± 0.05 min. The method was also applied for the determination of BUM in the presence of their degradation products formed under variety of stress conditions. Proposed method was validated for precision, accuracy, linearity range, recovery and robustness.