Development and validation of RP - HPLC method for the estimation of telmisartan in bulk and tablet dosage form

Abstract

A simple, precise, rapid, and reproducible RP -HPLC method was developed and validated for the determination of Telmisartan in Pharmaceutical dosage form. Separation was achieved under optimized chromatographic condition on a Zorbax- SB- 18;(ODS) column (150 X 4.6 mm i.d., particle size 3.5μ).The mobile phase consisted of Pentane sulphonic acid sodium salt mono hydrate, add 1ml of Perchloric acid and adjust the pH-2.7±0.05 with Triethyl amine: Methanol in the ratio 40: 60 v/v. An isocratic elution at a flow rate of 1.2 ml/ min at ambient temperature. The detection was carried out at 230 nm using waters UVVisible detector. The calibration curve was linear in the concentration range of 4-20μg/ ml (r2= 0.9999).The limit of detection and the limit of quantification were found to be 0.2515 mg/ml and 0.6623 mg/ml respectively. The amount of Telmisartan present in the formulation was found to be 99.95. The method was validated statistically using the SD, %RSD and SE and the values are found to be within the limits and the recovery studies were performed and the percentage recoveries was found to be 99.55± 0.7211 %. So, the proposed method was found to be simple, specific, linear, and rugged. Hence it can be used for applied for routine analysis of Telmisartan in the Pharmaceutical formulations. © 2012 IJDDR, M. Lakshmi Surekha et al.