Abstract

ESTIMATION OF TICAGRELOR IN COMMERCIAL DOSAGE FORM USING A SENSITIVE VALIDATED RP- HPLC METHOD

K. Madhuri*, Y. Srinivasa Rao, Varaprasada Rao. K. and Deepthi. R.

Abstract

Objectives: The main purpose of this study was to develop a simple, precise, accurate RP- HPLC method for estimation of Ticagrelor HCl in bulk and formulation. Materials and Methods: A gift sample of Ticagrelor HCL with an assay value of 99.2% w/w was obtained as a gift sample. Methanol and water used are of HPLC grade. Ticagrelor HCl tablets of 90mg with a brand name Brilinta® were purchased from local market. An Enable C18 column (250 X 4.6mm, 5μm particle size), flow rate of 1mL/min and a detection wave length 255nm was used for separation. Results: The mobile phase consisted of Methanol and water in the ratio (90:10, v/v). Retention time was found be 3.414 min. At λmax 255nm the method was found to be linear in the range of 5-30µg/mL with correlation coefficient (R²=0.9984) and regression equation was found to be y=18511x+357545. The percentage recovery values ranged from 99.44%-100.67%. Validation parameters were all validated according to ICH guidelines. Conclusion: This method can be successfully applied for estimation of Ticagrelor HCl in bulk and formulation.

Keywords: Ticagrelor HCl, Validation, RP-HPLC, Method development, Precision.