Quantitation of Valsartan in Human Plasma by High Performance Liquid Chromatography with Fluorescence Detection and its Application to Bioequivalence Study

A selective, accurate and precise high-performance liquid chromatographic method was developed for the quantitation of an angiotensin II receptor antagonist Valsartan in human plasma. HPLC separation was performed on a reversed phase Inertsil ODS-3V, C18 (250x4.6mm, 5μ) column, using an isocratic mobile phase of Acetonitrile: Water (60: 40, v/v) containing 0.1% Triethylamine and pH was adjusted to 3.5 with 10% orthophosphoric acid. The peak response in terms of peak area was measured with fluorescence detector, set at an excitation wavelength 250 nm and emission wavelength 371 nm, at room temperature.

The method was validated in terms of linearity, accuracy, precision, recovery, stock solution, freeze-thaw cycle, autosampler stability and bench top stability. Linearity was observed over a range of 20–1500 ng/mL. The validated method was successfully applied for the analysis of plasma samples from a Pharmacokinetic study.