2021, Volume 2 Issue 2 – Article 7


Development and Validation of RP-HPLC Method for the Estimation of Telmisartan in Bulk

Author (s): Usha Sen1*, Sudhir Kumar Sahoo2

1. Junior Research Associate in Regulatory Affairs, V-Ensure Pharma Technologies Pvt. Ltd.

2. Department of Pharmaceutical Analysis and Quality Assurance, Royal College of Pharmacy and Health Sciences, Berhampur, 760002, India


The aim of the present work was to develop a RP-HPLC (Reversed-Phase High-Performance Liquid Chromatography) method for the estimation of Telmisartan in bulk. Chromatographic separation of Telmisartan was achieved by using a C18 column. A Mobile phase containing of methanol:water (90:10) was pumped at the flow rate of 1 mL/min. Detection was performed at 291 nm. Validation parameters were evaluated according to the International Conference on Harmonization (ICH) Q2R1 guidelines. The calibration curve was linear in the concentration range 5-40 μg/mL for Telmisartan with regression coefficient 0.999. RSD values were found to be 0.142 % in the case of intra-day precision studies, whereas 0.333% in the case of inter-day precision. The limits of detection and quantification were found to be 0.052, 0.16 μg/mL, for Telmisartan respectively. This method was found to be good as the percentage recovery for Telmisartan were found to be 100.145%, which indicates that the proposed method is highly accurate.

Keywords: Telmisartan, RP-HPLC method development, UV-Vis Spectrophotometer, ICH guidelines.


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