Abstract

DEVELOPMENT, VALIDATION AND CHARACTERIZATION OF DEGRADANTS BY STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF ELIGLUSTAT

Vikrant Salode*, Madhuri Game and Gouri Salode

ABSTRACT

Objective: The aim of this study was to develop a validated stability indicating Reverse Phase High-performance liquid chromatography (RP-HPLC) method for estimation of Eliglustat and characterization of degradants by mass spectroscopy. Method: The RP-HPLC method was developed using the HiQSil C18 column (250 x 4.6 mm, 5μm) and the mobile phase was selected Methanol: Ammonium Acetate Buffer (80:20 v/v) with a flow rate of 1.0 ml / min with detection wavelength selected at 284 nm. Drug retention time (RT) was at 3.560 min ± 0.034 min. Eliglustat has subjected to various stress testing conditions, such as hydrolysis of acid and base, thermal degradation, oxidation and photolysis. Result: The method has been validated with regard to linearity, accuracy, precision and robustness. Linear regression analysis data indicated a good linear relationship with a correlation coefficient (R2) of 0.987 over the 5-30 μg/ml concentration range. Stress results showed that there was a significant degradation of drug in acidic condition, the degradation product of which characterized using LC-MS technique Conclusion: The method developed was found to be quick, sensitive, selective, precise, accurate, and robust for Eliglustat analysis which can be adopted for routine drug analysis.

Keywords: High performance liquid chromatography (HPLC), Mass spectroscopy (MS) Eliglustat, Stress degradation, Validation.