Abstract

STABILITY INDICATING ASSAY METHOD DEVELOPMENT AND VALIDATION FOR NEBIVOLOL AND TELMISARTAN IN ITS COMBINED PHARMACEUTICAL DOSAGE FORM

Aashka Joshi* and Dr. C. N. Patel

Abstract

A new simple, rapid and sensitive stability indicating RP-HPLC method has been developed for the determination of Nebivolol and Telmisartan in its combined pharmaceutical dosage form. The method employs Agilent C18 (250 x 4.6mm; 3μm particle size) column for the chromatographic separation and Acetonitrile: 0.05 M (pH 6.5) Disodiumhydrogen (NA2HPO4) buffer was used as a mobile phase. Separation was completed within 10 min with a flow rate of 1 ml/min and detection was at 235 nm. The retention time of Nebivolol and Telmisartan was found to be 2.920 min & 8.093 min respectively. The proposed method was found to have the linearity in the concentration range of range of 25-75 μg/ml for Nebivolol and 100-300 μg/ml for Telmisartan. Linearty regression coefficient was not less than 0.999. The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 98.04 – 101.11 % of Nebivolol and 99.92-100.37 % for Telmisartan. LOD and LOQ were found to be within limit. The results obtained on the validation parameters met ICH Guidelines. The method was found to have suitable application in routine laboratory analysis with high degree of accuracy and precision.

Keywords: Nebivolol, Telmisartan, RP-HPLC Estimation, Analytical Method Validation.