Validated Stability Indicating High Performance Liquid

Background: a simple, sensitive, selective and precise stability indicating hplcmethod is developed and validated for the assay of ambrisentan in pharmaceuticaldosage form. methods: separation of the drug was achieved on agilent zorbax c18column (250 mm × 4.6 mm i.d., 5 ?m particle size) under the isocratic mode ofelution. the solvent system consisted of 0.1m potassium dihydrogen phosphate buffer(ph was adjusted to 4.4 with orthophosphoric acid) and methanol (30:70 v/v) at a flowrate of 1.0 ml/min. the method was carried out in the absorbance mode at 210 nm.the method was statistically validated according to international conference onharmonization guideline. ambrisentan was subjected to stress degradation studiesunder acidic, basic, oxidative, thermal and photolytic conditions. results: the systemwas found to give compact peak for ambrisentan (retention time is 3.315 min). themethod was linear in the range of 1 - 150 ?g/ml. the linear regression data for thecalibration plot showed good relationship (r2 = 0.9996). the relative standarddeviation and mean recovery values at different concentration levels were withinlimits. the performance of the method was not changed when small variations in theexperimental conditions were made. degradation products resulting from stressdegradation studies did not interfere with the detection of ambrisentan. conclusions:the proposed stability indicting hplc method is simple, precise, accurate, robust andselective. this method can be used for quantification of ambrisentan in bulk drug andin pharmaceutical dosage forms.