1. S DIVYA TEJA. BANDA - Research Scholar, Bhagwant University, Ajmer, Rajasthan, INDIA-305004.
2. Dr. MOHD JAVED NAIM - Faculty of Pharmacy, Bhagwant University, Ajmer, Rajasthan, INDIA-305004.
RP-HPLC method for estimation of Edoxaban in bulk and pharmaceutical dosage forms was obtained with Hypersil ODS C18 (100mm×4.6 mm, 5µm particle size); Shimadzu LC-20AT Prominence HPLC system, equipped with SPD 20A detector and mobile phase contained a mixture of Potassium di-hydrogen phosphate (pH adjusted to 3.5 with orthophosphoric acid) and Acetonitrile (30:70, v/v) was delivered at a flow rate of 1 mL/min. Quantitation was attained at 230 nm depends on peak area. The retention time of Edoxaban was 3.677 min. Linearity was established for Edoxaban in the range of 10.5-18 µg/mL with correlation coefficients (r=0.999) and the percentage recoveries were between 99.74 %-100.70 % for Edoxaban respectively. The RSD % values of accuracy for Edoxaban were found to be < 2 %, which indicate accuracy of the proposed method. The RSD % values of precision were found to be 0.121% for Edoxaban respectively and for ruggedness were found to be 0.43% and 0.94 % for Edoxaban respectively, reveal that the proposed method is precise. LOD values were found to be 0.03 µg/mL for Edoxaban and LOQ values were found to be 0.09 µg/mL for Edoxaban. The RSD % values of robustness studies were found to be < 2 %, which indicate robustness of the proposed method. These reports show that the proposed method was accurate and precise for determination of Edoxaban in bulk and pharmaceutical combined dosage forms. The developed method is simple, precise, and accurate. Hence, the RP-HPLC method can be applicable for the routine analysis of Edoxaban in bulk and pharmaceutical dosage forms.
Edoxaban, RP-HPLC, Quantitation, ICH guidelines, correlation coefficients, RSD %, accuracy