Abstract

METHOD DEVELOPMENT, VALIDATION AND STABILITY ESTIMATION OF TRANDOLAPRIL ASSAY AND ITS ORGANIC IMPURITIES BY RP-UPLC-MS

B. Anjaneyulu Reddy*, P. Radhakrishnanand, Md. Irshad Alam, J. Satish and Arjun Siliveri

Abstract

A novel, rapid, specific and stable RP-UPLC-MS assay and its Organic Impurities method was developed and validated for the estimation of Trandolapril in Active pharmaceutical ingredient. The separation was carried out by using a mobile phase consisting of Solution A: 0.1% TFA in water, Solution B: 0.1% TFA in Acetonitrile.Solvent- Acetonitrile: water (2:8).The column used for separation wasColumn: Acquity UPLC BEH C18, 100 mm x 2.1 mm x1.7μm with flow rate of 0.4ml/min and wavelength at 210nm. The retention time for Trandolapril was 5.56. The stability of the developed method was estimated by stress testing of Trandolapril by exposing them to various forced degradation conditions. The method was also validated in terms of accuracy, precision, linearity, system suitability, robustness and ruggedness as per ICH guidelines.

Keywords: Trandolapril, Assay, Organic Impurities, UPLC, LC-MS, ICH, Forced Degradation.