Development and Validation of Method for the Estimation of Prasugrel Base in Prasugrel Tablets by Powder X-Ray Diffractometer (PXRD)

A PXRD quantitative method is developed and validated for the estimation of Prasugrel Base in Prasugrel tablets 5mg and 10mg. The PXRD conditions for the Slow scan method developed for the estimation of Prasugrel base at 13.3°2 with a radiation source of Copper Kα1 (λ=1.54060A°). The Angular range was 13.0 to 13.5°2 with the Voltage and Current set to 40KV and 40mA and a step size of 0.02° along with sample rotation of 30 rpm. The scan type is Locked coupled, continuous with a high sensitive Lynxeye detector. The developed method was validated for Specificity, Sensitivity (LOD and LOQ), Linearity, Precision (Method
precision and intermediate precision), accuracy and Robustness. The PXRD method is Linear with a concentration range of 0.25% to 2.0% w/w. with correlation coefficient of 0.996. The recoveries ranged between 104.7% - 112.0% for LOQ levels and 83.1% - 102.1% for remaining levels. The Method was found to be specific, linear, sensitive, precise, accurate and robust for the estimation of Prasugrel base in Prasugrel tablets.