A simple, specific and validated reverse phase high performance liquid chromatography method was developed for determination of drug related substances (impurity) of Darunavir in formulation. Method development includes optimization of stationary phase (column) and mobile phase flow rate for the resolution of six known impurities and one unknown impurity and Darunavir. Development of HPLC method for estimation of Darunavir related substance in formulation was carried out on Zorbax SB-C8, 250 x 4.6mm, 5µm by using a gradient mode of the mobile phase flow rate at 1ml/min with the same mobile phase as, ACN : Buffer pH 4.0 (Mobile phase B:Mobile Phase A). The stability-indicating capability of the method was proved through the solution state stability, solid state study and it was concluded that purity threshold was found to be greater than purity angle. A good linear relation exists over the range of 50 to 150 % specification level with a correlation coefficient value of 0.9998Validation of the method was successfully established by performing various validation parameters such as specificity, precision, linearity, accuracy, LOD, LOQ, robustness, ruggedness according to ICH guidelines.zones. ICH guidelines also guide qualification, identification,
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