Stability-indicating LC method for determination of tadalafil in bulk drug and pharmaceutical dosage form

A novel stability-indicating LC assay method for quantitative determination of tadalafil in bulk drug and pharmaceutical dosage form in the presence of forced-degradation products was developed and validated An isocratic reversed phase LC method was developed to separate the drug from its degradation products using a Zorbax SB-C-18 column and water-acetonitrile mixture as a mobile phase. Detection was carried Out of the wavelength of 235 nm. Tadalafil was subjected to stress conditions in order to perform its hydrolytic (acid, base), oxidative, photolytic. and thermal degradation Degradation of tadalafil was observed in the presence or acid, base, and 30% H2O2 The drug was found to be stable tinder other stress conditions. The signals of degradation products were well-resolved from the main peak of tadalafil Percentage recovery of tadalafil in pharmaceutical dosage form ranged from 98,99% to 101.25%. The developed method was validated with respect to linearity, accuracy (recovery). precision. specificity, and robustness Forced degradation studies proved the stability-indicating power of the method.