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.