ABSTRACT

The objective of the current study was to develop a simple, precise and accurate RP-HPLC assay method and its validation for determination of ambrisentan in pharmaceutical tablet dosage form. Gradient RP-HPLC separation was achieved on an analytical Primsil C18 R column (250 mm × 4.6 mm; 5 µm particle size) using mobile phase containing mixture of acetonitrile: water (65:35 V/V). The developed method was validated for specificity, linearity, precision, accuracy and robustness study. The method was linear in the drug concentration range of 10-50 µg mL-1 with a correlation coefficient 0.998. The percent RSD values were found to be less than 2 %, indicating the developed method was also robust. The method was completely validated and shows satisfactory result for the all method parameter. Hence it is concluded that the proposed method is precise, simple, sensitive, accurate, rugged and rapid and can be applied successfully for the estimation of ambrisentan in pharmaceutical dosage form.