Abstract

SIMULTANEOUS ESTIMATION AND VALIDATION OF TRANDOLAPRIL AND VERAPAMIL IN BULK AND PHARMA CEUTICAL DOSAGE FORM BY RP-HPLC METHOD.

E Tejashwi*, S. Kiran Kumar and B. Siddartha

ABSTRACT

A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination Trandolapril and Verapamil in pharmaceutical dosage form. The column used was Hypersil BDS C18 (100mm x 4.6 mm, 5) in isocratic mode, with mobile phase containing phosphate buffer and acetonitrile (60:40 v/v). The buffer is prepared by adding 2.72gm of potassium dihyrogen ortho phosphate in a 1000ml of volumetric flask add about 900ml of milli-Q water added and degas to sonicate and finally make up the volume with water then added 0.5ml of triethylamine then pH adjusted to 2.8 with dil. orthophosphoric acid solution. The flow rate was 0.8ml/ min and effluents were monitored at 240 nm. The retention times of Trandolapril and Verapamil were found to be 2.905 min and 3.481 min, respectively. The linearity for Trandolapril and Verapamil were in the range of 1-6 µg/ml and 60-360 µg/ml respectively. The recoveries of Trandolapril and Verapamil were found to be 98.58% to 100.64% w/v and 98.28% to 100.82%w/v, respectively. The proposed method was validated and successfully applied to the estimation of Trandolapril and Verapamil in combined tablet dosage forms.

Keywords: Trandolapril, Verapamil, Buffer, Acetonitrile, Validation and ICH Guidelines.