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Abstract

DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD FOR THE DETERMINATION OF TICAGRELOR IN BULK AND PHARMACEUTICAL DOSAGE FORM

Pramod Sarraf*, Chandanam Sreedhar, T. Srinivasa Rao, Harsha K. Tripathy, Deepthi D. Kini and Preksha Adhikari

Abstract

An anti-platelet drug decreases platelet aggregation and inhibit thrombus formation. The objective of the present study is to develop and validate the new analytical methods for the estimation of ticagrelor in bulk drug and pharmaceutical formulations. The new RP-HPLC method for the estimation of Ticagrelor was found out by using different chromatographic parameters. Chromatography was performed by gradient reverse phase separation using a Water’s XBridge C18 column of particle size 5μ 250×4.6mm. The separations were achieved at the UV detection at 254nm using the mobile phase of Acetonitrile : Triethylamine Formic Acid in the ratio of 60:40. Flow rate was 1ml/min and the injection volume was set at 20 μl with 10 mins of runtime. The retention time was observed at 4.763. The method was validated by using various validation parameters like accuracy, precision, linearity, limit of detection (LOD), limit of quantification (LOQ). These results showed the method could find practical application as a quality control tool for analysis of the drug in its pharmaceutical dosage forms in quality control laboratories. The standard curve was linear over a working range of 10- 60 μg/ml and gave an average correlation factor of 0.9998 for ticagrelor. The limit of detection and the limit of quantitation were found to be 0.462μg/ml and 1.540μg/ml respectively. The method showed good recoveries and relative standard deviations of intra and inter day assay less than 2. This method can be easily and conveniently used for routine analysis of ticagrelor in bulk and tablet dosage forms.

Keywords: Ticagrelor, RP-HPLC, Accuracy, Precision, Linearity, LOD, LOQ.


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