A validated stability indicating method of UV-Spectrophotometry for the estimation of ticagrelor in bulk and marketed formulation

摘要

To develop and validate a simple, rapid, accurate and economical UV Spectrophotometric method for the determination of Ticagrelor in bulk and its marketed product. UV- Spectrophotometric method was performed by using UV/Vis double beam spectrophotometer with spectral band width of 1 nm and 1.0 cm matched quartz cells and glass cells were used for UV regions respectively. Methanol and O-phosphoric acid was used as solvents in the ratio of 20:80 respectively and the maximum absorbance of Ticagrelor was observed in methanol & O-phosphoric acid at 237nm in UV region. The linear calibration range was found to be 2μg/mL to 10μg/mL in UV region. The correlation coefficient (R2) is 0.9855 and the regression equation is y=0.0808x-0.0022 in UV region. The method was validated in terms of Linearity, Precision, Accuracy, Robustness, LOD and LOQ as per ICH guidelines.