METHOD DEVELOPMENT AND VALIDATION OF TELMISARTAN BY USING RP-HPLC
Keywords:
Telmisartan, RP-HPLC, Method Validation, optimized.Abstract
A straightforward, reliable reverse phase RP-HPLC technique has been devised and verified for the quantification of Telmisartan in both bulk and pharmaceutical dose forms. Chromotography was estimated by Stationary phase is STD Ascentis C18 (250mm×4.6mm 5μm) for elutant separation, and the Mobile phase is 0.01N Kh2Po4 and Acetonitrile in the ratio of 8:2 at a flow rate 0.5ml/min was maintained, maximum wave length at 296.0 nm, Temperature was set to 30oC. The average retention time of Telmisartan were found to be 5.100 min respectively. By injecting the standard six times, the system suitability characteristics were evaluated, and the results were significantly below the acceptance requirement (Limit of less than 2). A linearity analysis was conducted between 25% and 150% levels, and the R2 value was found to be 0.999. Several validation criteria, including precision, accuracy, LOD, LOQ, and robustness, were determined to be within accepted limits. % recovery was obtained as 99.49% for Telmisartan respectively. The approach was discovered to be simple, accurate, sensitive, quick, and cost effective, with a runtime of less than 30 minutes. In practice, this approach may also be used to determine assay in tablet formulation.
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Copyright (c) 2024 P.R. Sudha Rani
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