Assessments of valsartanin the presence of nebivolol or amlodipine in solid formulations and its discriminative dissolution behavior via RP-HPLC and RP-UPLC methods

Abstract

THE current work provides method development and validation of a rapid, robust, precise andaccurateRP-HPLCandRP-UPLCfortheassessmentofValsartan(VAL)inthepresence of Nebivolol (NEB) or Amlodipine (AML) in their combined solid dosage form, following the ICH instructions. In RP-HPLC, Separation was achieved on an Inertsil column, (C18, 150 mm x 4.6 mm, 5μm) with (30:20:50 v/v%), mobile phase of (buffer pH 3.0: acetonitrile: methanol) in an isocratic mode with a flow rate 1.0 mL/min and using photodiode array (PDA) detection at 281 nm. However, in RP-UPLC, Mobile phase was phosphate buffer pH 3.0 and acetonitrile in a ratio of (55:45 v/v%) at a flow rate 0.3 mL/min on an Eclipse Plus column, (C18, 1.8 µm, 50 mm × 2.1 mm), while detection at 240 nm on a PDA detector. Calibration curves were linear over the concentration ranges of (0.80-72.00,0.05-4.50) and (4.00-144.00, 0.125-4.50) µg/mL, for the assay and in-vitro drug release profile of (VAL, NEB) and (VAL, AML), respectively. In-Vitro dissolution studies revealed that not less than (NLT) 85% of the labeled amount of VAL and AML was released within 15 min and NLT 85% of the labeled amount of NEB was dissolved within 20 min from their fixed combination solid dosage forms.