Development and Validation of Method for the Estimation of Telmisartan as Active Pharmaceutical Ingredient in Tablet Dosage form and Prepared Spherical Agglomerates by RP-HPLC
The Present work was designed to develop and validate an accurate, precise and rapid method for the estimation of Telmisartan as Active Pharmaceutical Ingredient (API) as well as in tablet dosage form and prepared spherical agglomerates by RP-HPLC. The developed method was found to be simple, accurate, precise and sensitive. The separation was achieved on an Isocratic High Pressure Liquid Chromatography (HPLC) (Thermo Scientific) using pumps Jasco PU 2080 Plus, UV detector, column oven (Jasco), and a Reverse Phase C-18 (phenyl) Column (25 cm x 4.6 mm) i.d., particle size 5 μm. The HPLC system was run with flow rate: 0.8 ml/min Injection Volume: 10μl and run time: 10 min, Detector temp: 40 oC. The method was validated for specificity, precision, linearity, and accuracy, robustness, LOD and LOQ parameters. The recovery range was within the range of 99.0–102.0% and the method could be successfully applied for the routine analysis of the drug substance as well as the spherical agglomerates prepared by crystallo coagglomeration technique.
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