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Stability-indicating UPLC method for determination frusemide, spironolactone and their degradation products in active pharmaceutical ingredients and pharmaceutical dosage form

Ankit K.Bhatia, P.P.Dahivelkar

A simple, precise, accurate isocratic stability indicating ultra-performance liquid chromatographic (UPLC) method was developed for quantitative determination of Frusemide, Spironolactone in bulk sample and solid pharmaceutical dosage form in the presence of degradation products. Isocratic RP-UPLC separation was achieved on Waters Aquity Bridge Ethylene Hybrid (BEH) C18 (100mm×2.1mm, 1.7µ) column using a mobile phase containing a mixture of sodium dihydrogen phosphate monohydrate (adjust pH 3 with ortho-phosphoric acid) and acetonitrile (57:43) (v/v) at flow rate of 0.25 ml min-1. The detection was carried out at 235nmby using Tunable Ultra-Violet (TUV) detector.The runtimewas 7min for performing the analysis in which two main compounds were separated. The developed method was validated as per ICH guideline with respect to linearity, precision, accuracy and robustness. Degradation products produced as a result of stress studies did not interfere with the detection of frusemide and spironolactone; therefore, the assay can be considered as stability-indicating.