TITLE:
Simple Estimation of Bosentan in Tablet Formulation by RP-HPLC
AUTHORS:
Selvadurai Muralidharan, Jaya Raja Kumar
KEYWORDS:
Estimation; Validation; RP-HPLC; Bosentan
JOURNAL NAME:
American Journal of Analytical Chemistry,
Vol.3 No.11,
November
16,
2012
ABSTRACT: A simple, precise, and accurate method is developed and validated for the analysis of Bosentan tablet formulation. The method has shown adequate separation of the ingredients from Tablets. Separation was achieved on a C18 column using a mobile phase consisting of acetonitrile: 10 Mm ammonium acetate (pH 4.5) buffer (70:30, v/v) at a flow rate of 1.0 ml/min and UV detection at 265 nm. This new method is validated as per the ICH, which includes accuracy, precision, selectivity, linearity and range, robustness and ruggedness. The current method demonstrates good linearity over the range of 5 - 70 ng/ml of bosentan with r2 of 0.999. The average recovery of the method is 98.6%. The degree of reproducibility of the results obtained as an outcome of small deliberate variations in the method parameters and by changing analytical operator has proven that this method is robust and rugged.