RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TELMISARTAN IN BULK AND TABLET DOSAGE FORM
Journal Title: International Journal of Drug Regulatory Affairs - Year 2013, Vol 1, Issue 2
Abstract
A simple, sensitive, precise and specific reverse phase high performance liquid chromatographic method was developed and validated for the determination of Telmisartan in bulk and tablet dosage forms. It was found that the excipient in the tablet dosage forms does not interfere in the quantification of active drug by proposed method. The HPLC separation was carried out by reverse phase chromatography on RP18, column (250×4.6mm) with a mobile phase composed of 0.025M potassium dihydrogen phosphate : acetonitrile : methanol (45:50:5) at a flow rate of 1ml/min. The detection was monitored at 216 nm. The calibration curve for Telmisartan was linear from 100 to 500 ng/ml. The interday and intraday precision was found to be within limits. LOD and LOQ for Telmisartan were found to be 27 ng/ml and 83 ng/ml. Accuracy and reproducibility were also found within range. The proposed method has adequate sensitivity, reproducibility and specificity for the determination of Telmisartan in bulk and its tablet dosage forms.
Authors and Affiliations
Bhadoriya Upendra, Dhaked Hemant, Danodia Abhinandan Kumar
Keywords
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- EP ID EP336532
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