Stability indicating RP-HPLC method for quantification of Edoxaban tosylate

Abstract

Edoxaban tosylate is a member of the novel oral anti-coagulants (NOACs) class of drugs, and is a rapidly acting, oral, selective factor Xa inhibitor. The main objective of present study is to develop a stability indicating RP-HPLC method for quantification of edoxaban tosylate. The separation of edoxaban tosylate was achieved on LC-GC Qualisil gold C18 (250 X 4.6 mm i.d., 5μ) using a mobile phase of 65:35 % v/v acetonitrile and 0.2% TEA in water (pH adjusted to 3 with OPA) with 1ml/min flow rate at a wavelength of 260 nm. The linearity of the proposed method was in the range of 2-25 µg/ml with R2 value of 0.9996. The LOD and LOQ was found to be 0.46 µg/ml and 1.40 µg/ml for edoxaban tosylate respectively. The developed method was able to separate all the degradants from each other and also from API. The developed methods were validated for various parameters like Specificity, Linearity, Precision, Accuracy, Limit of detection (LOD), Limit of quantification (LOQ) and Robustness and is in accordance with ICH guidelines.