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Abstract

SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR QUANTITATIVE ESTIMATION OF TICAGRELOR IN BULK DRUG AND THEIR DOSAGE FORMS BY USING HYDROTROPIC AGENT

Sonam Onkari*1, Arpana Gaur Mishra1, Surekha1, Prabhat Jain2

1Sarojini Naidu Government Girls P.G. (Autonomous) College, Bhopal (M.P.)
2Scan Research Laboratories, Bhopal (M.P.)

ABSTRACT

A novel, simple, fast and reproducible UV spectrophotometric method was developed using 2M sodium acetate as hydrotropic solubilizing agent for the estimation of poorly water soluble drug Ticagrelor in bulk and in pharmaceutical dosage form. There was more than 58 fold enhancement in the solubility of ticagrelor in 2M sodium acetate solution as compared to solubility in distilled water. Various organic solvents such as methanol, chloroform, dimethyl formamide and acetonitrile have been employed for solubilization of poorly water-soluble drugs to carry out spectrophotometric analysis. Drawbacks of organic solvents include their higher cost, toxicity and pollution. Hydrotropic solubilization may be a proper choice to preclude the use of organic solvents. It involves the addition of large amount of a second solute to increase the aqueous solubility of the first solute. Ticagrelor exhibits absorption maximum at 256 nm. Sodium acetate did not show any absorbance above 240 nm and thus no interference in the estimation of drug was seen. Beer’s law was found to be obeyed in the concentration range of 5-25μg/ml. In this method, there is no interference from any common pharmaceutical additives and diluents. The correlation co-efficient (' r2 value) for ticagrelor was 0.999.The results of analysis have been validated as per ICH guidelines. The percentage recovery of ticagrelor ranged from 97.84 to 100.16% in pharmaceutical dosage form. Results of the analysis for accuracy, precision, LOD, LOQ and were found to be satisfactory. Therefore the methods can be used for routine monitoring of ticagrelor in industry in the assay of bulk drug and tablets.

Keywords: Ticagrelor, Hydrotropy, Sodium acetate, Spectrophotometry


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