• ABHISHEK LAWSARE
• RAJESH LOHIYA
• Dr. MILIND UMEKAR
• SHYAM RANGARI
• Vaishnavi Umretkar

In RP-HPLC method, the conditions were optimized to obtain an adequate separation of eluted compounds. To separate the title components, a variety of mobile phase compositions were initially used. Mobile phase and flow rate selection was based on peak parameters (height, tailing, theoretical plates, capacity or symmetry factor), run time and resolution. The mobile phase containing mixture of Methanol:Acetonitrile(75:25v/v)with a flow rate of 1.0 ml/min is quite robust. The optimum wavelength for detection was 282 nm at which better detector response for both the drugs was obtained. The retention time of Eliglustat was found to be 4.014 min. System appropriateness studies on freshly manufactured stock solutions were done to gauge its efficacy. The calibration was linear in concentration range of 20 to 140 μg/ ml, with regression 0.9997. The low values of % R.S.D indicate the method is precise and accurate. The mean recoveries were found above 100.53 % for the drug. By performing validation in accordance with ICH guidelines, the Method was examined. Eliglustat in its pharmaceutical dosage form is routinely analyzed using the method by RP-HPLC as a result of its validation.

Eliglustat, RP-HPLC, Gaucher Disease, Pharmaceutical dosage form, etc.

"Stability-Indicating Method Development and Validation for Estimation of Eliglustat in Formulation by High Performance Liquid Chromatography.", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.11, Issue 3, page no.a208-a223, March-2024, Available :http://www.jetir.org/papers/JETIR2403028.pdf

"Stability-Indicating Method Development and Validation for Estimation of Eliglustat in Formulation by High Performance Liquid Chromatography.", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.11, Issue 3, page no. ppa208-a223, March-2024, Available at : http://www.jetir.org/papers/JETIR2403028.pdf