Abstracto

Stress degradation studies on trandolapril and development of a stability-indicatingHPLCassaymethod for pharmaceutical dosage form

Dantu Durga Rao, A.Malleswara Reddy, Shakil S.Sait, K.Mukkanti

A stability- indicating HPLC method was developed for the quantitative determination of trandolapril in pharmaceutical dosage forms in the presence of degradation products. It involved a X terra RP18 150 mm 4.6 mm, 5 mcolumn. The separationwas achieved on gradientmethod. The mobile phase A contains a mixture of pH 3.0, 10mM Na2HPO4 buffer: acetonitrile (65:35, v/v) and the mobile phase B contains a mixture of pH 3.0, 10mM Na2HPO4buffer: acetonitrile (45:55, v/v). The flowratewas 1.2mLmin-1 and the detection wavelength was 210 nm. The retention time of trandolapril is 5.7 min. The total runtime was 20 min within which drug and degradation products were separated. Trandolapril was subjected to different ICH prescribed stress conditions. Degradation was found to occur in hydrolytic and oxidative stress condition, while drug was stable to thermal and photolytic stress conditions. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The method developed was successfully applied to the determination of trandolapril in pharmaceutical preparations. The developed RP-HPLC method was validated with respect to linearity, accuracy, precision and ruggedness.