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Development and Validation of a Reversed-Phase HPLC Method for the Simultaneous Determination of Telmisartan and Its Related Compound B (Positional Isomers) in the Bulk Drug

Kamlesh M. Patel, Upendra R. Patel, Ashaben D. Patel


A simple, selective, accurate, precise and linear RP-HPLC method was developed and validation for Simultaneous determination of Telmisartan and its related Compound B 4ʹ-[(1,7-Dimethyl-2'-propyl[2,5'-bi-1H-benzimidazol]-1'-yl)methyl][1,1'-biphenyl]-2-carboxylic acid; 4'-[(1,7'-dimethyl-2'-propyl-1H,1'H-2,5'-bibenzo[d]imidazol-1'-yl)methyl]biphenyl-2-carboxylic acid; was accomplished in the bulk drug and synthesis for drug and a tablet formulation using a Reversed Phase High Performance liquid chromatography method with UV detection separation was achieved on Inertsil ODS-3V column (150 × 4.6 mm, 5 μm) (GL Science) as stationary phase with binary gradient mode solvent phase A. composed of KH2PO4 (potassium dihydrogen orthophopsphate) buffer (PH adjust =3.5, with triethylamine) and phase B of use filter and degas acetonitrile. The flow rate of the mobile phase was 1.0 mL/min and the total elution time including the column re-equilibration was approximately 30 min. The UV detection wavelength was 246 nm, injection volume was 10 μL and experiments were conducted at 30 °C temperature. The developed method was validated in terms of system suitability, selectivity, linearity, range, precision, accuracy, limits of detection and quantification the for the related compound B, short term and long term stability of the analysts in the prepared solution and robustness, following the ICH guidelines therefore the proposed method was suitable for the simultaneous determination of telmisartan and its related compound B.

Keywords: binary gradient, degas acetonitrile, precision, system suitability, telmisartan

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