Open Access Open Access  Restricted Access Subscription or Fee Access

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.

Full Text:


References Telmisatan.

Pritor prescribing information.

Sharpe M., Jarvis B., Goa K.L. Telmisartan: a review of its use in

hypertension, Drugs. 2001; 61(10): 1501–29p.

Sanchis-Gomar F., Lippi G. Telmisartan as metabilic modulator: a new perspective in sports doping, J Strength Condit Res. 2011; 1.

Cytoplasmic and Nuclear Receptors: Advances in Research and Application. 2011 Edn. Scholarly Edns, 2012, 21p. Retrieved 2 April 2013.

Feng X., Luo Z., Ma L., et al. Angiotensin II receptor blocker telmisartan enhances running endurance of skeletal muscle through activation of the PPAR-δ/AMPK pathway, J Cell Mol Med. 2011; 15(7): 1572–81p.

He H., Yang D., Ma L., et al. Telmisartan prevents weight gain and obesity through activation of peroxisome proliferator-activated receptor-dependent pathways, Hypertension. 2010; 55(4): 869–79p.

Li L., Luo Z., Yu H., et al. Telmisartan improves insulin resistance of skeletal muscle through peroxisome proliferator-activated receptor-activation, Diabetes. 2012; 62(3): 762–74.

Chemical Book; HTTP://

International Conferences on Harmonization of Technical Requirements for the Registration of pharmaceutical for human use(ICH), Guideline Q2 (R)-validation of Analytical procedures; Text and Methodology (last reviewed at 3/1/2011)

Bliesner D.M. Validating Chromatographic Method: A Practical Guide. New Jersey, USA: Wiley; 2007, 97–130p.

Kazakevich Y., Lobrutto R. HPLC for Pharmaceutical Scientists. New Jersey, USA: Wiley and Sons Inc.; 2007, 455–91p.


  • There are currently no refbacks.