Articles Accepted

Stability Indicating HPLC Method for the estimation of Eliglustat Tartrate
by Mrs. MINAL, 26 Feb 2020

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 and pH of mobile phase adjusted to 3.0. The column used was HiQ Sil C-18 (250 mm x 4.6 mm) as stationary phase at a flow rate of 0.7 mL/min. Retention time for Eliglustat tartarate was found to be 5.9 min. The eluted compounds were detected using PDA detector. The drug was subjected to stress testing as per ICH Q1A (R2) guideline. The degradation products of Eliglustat did not interfere with the retion time of Eliglustat. The calibration curve was found to be linear over a concentration range of 10-50 µg/mL. For the calibration plots R2of 0.9995 was found for the linear regression analysis indicating good linear relationship. The accuracy of the developed method was in the range of 99.87-100.62 %. The limit of detection was found to be 0.23 µg/mL and limit of quantification of Eliglustat was 0.68 µg/mL.

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