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.
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