STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF ELIGLUSTAT TARTRATE

Abstract

For determination of eliglustat tartrate, a new, specific, simple, accurate (recovery) and precise stability indicating HPLC method has been developed and validated according to ICH Q2(R1) guidelines. The HPLC method was developed using acetonitrile: 0.1 % orthophosphoric acid 40:60 (V/V) as mobile phase, with pH of mobile phase adjusted to 3.0. The column used was HiQSil C-18 (250 mm x 4.6 mm, 5 μm) as stationary phase at a flow rate of 0.7 mL min-1. Retention time for eliglustat tartarate was found to be 5.9 min. The eluted compounds were detected using a PDA detector. The drug was subjected to stress testing as per ICH Q1A (R2) guideline. The degradation products did not interfere with the retention time of eliglustat. The calibration curve was found to be linear over a concentration range of 10-50 µg mL-1. For the calibration plots, R2 was found as 0.9995, indicating good linear relationship. The accuracy of the developed method was in the range of 99.87-100.62 %. The limit of detection of eliglustat was found to be 0.23 µg mL-1 and limit of quantification was 0.68 µg mL-1.