Stability indicating RP-HPLC method for determination of Trandolapril (TP) in pure and pharmaceutical formulation

A simple, rapid and accurate and stability indicating RP-HPLC method was developed for the determination of TP in pure and tablet forms. The method showed a linear response for concentrations in the range of 20-60 μg/mL using Acetonitrile: Phosphate Buffer solution in the ratio (60:4 0) as the mobile phase with detection at 210 nm and a flow rate of 0.8 mL/min and retention time 2.645 min. The value of correlation coefficient, slope and intercept were, 0.999, 48442.82 and 69569.6, respectively. The method was validated for precision, recovery, ruggedness and robustness. The drug undergoes degradation under acidic, basic, peroxide and thermal degradation conditions. All the peaks of degraded product were resolved from the active pharmaceutical ingredient with significantly different retention time. As the method could effectively separate the drug from its degradation product, it can be employed as a stability indicating one.

Author(s): Manju Latha. Y. B, Gowri Sankar. D

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