An Improved Assay Method For The Estimation Of Ticagrelor Hydrochloride By Reverse Phase Liquid Chromatography

Abstract

The current investigation was carried out to develop and validate a fairly simple, accurate, precise, reproducible and robust RP-HPLC method for the estimation of Ticagrelor Hydrochloride. The separation was achieved using Agilent Infinity 1220, Infinity Fast-LC (Pressure limit up to 600 bars) with auto sampler and PDA detector. The Chromatographic analysis was performed on ZORBAX Eclipse Plus 300SB C18 (250 x 4.6mm, 5.0 micron, PN 880995-902) column. Mobile phase consist of (A) Acetonitrile: (B) 20mM Potassium dihydrogen ortho phosphate buffer (40:60 v/v) at a flow rate of 1.0 ml/min. The method showed linear in the mentioned concentrations having line equation y = 22.848x + 1.3214 with correlation coefficient R2 of 0.9995. The recovery values for Ticagrelor ranged from 99.63% to 100.34%. The % RSD was 0.49% and 0.54%, respectively for intraday and interday precision. The limit of detection and limit of quantification were 0.05μg/mL and 0.20μg/mL respectively. Newly developed method was statistically validated for accuracy, precision, linearity and solution stability; hence it is directly applicable for the estimation of Ticagrelor up to trace level in routine analysis.

The current investigation was carried out to develop and validate a fairly simple, accurate, precise, reproducible and robust RP-HPLC method for the estimation of Ticagrelor Hydrochloride. The separation was achieved using Agilent Infinity 1220, Infinity Fast-LC (Pressure limit up to 600 bars) with auto sampler and PDA detector. The Chromatographic analysis was performed on ZORBAX Eclipse Plus 300SB C18 (250 x 4.6mm, 5.0 micron, PN 880995-902) column. Mobile phase consist of (A) Acetonitrile: (B) 20mM Potassium dihydrogen ortho phosphate buffer (40:60 v/v) at a flow rate of 1.0 ml/min. The method showed linear in the mentioned concentrations having line equation y = 22.848x + 1.3214 with correlation coefficient R2 of 0.9995. The recovery values for Ticagrelor ranged from 99.63% to 100.34%. The % RSD was 0.49% and 0.54%, respectively for intraday and interday precision. The limit of detection and limit of quantification were 0.05μg/mL and 0.20μg/mL respectively. Newly developed method was statistically validated for accuracy, precision, linearity and solution stability; hence it is directly applicable for the estimation of Ticagrelor up to trace level in routine analysis.