ANALYTICAL METHOD AND VALIDATION FOR DETERMINATION OF ELINZANETANT IN BULK FORM AND MARKETED PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC

An efficient and simple RP-HPLC method has been developed and validated for the estimation of Elinzanetant in bulk and marketed pharmaceutical dosage forms. The mobile phase used for the chromatographic runs consisted of Methanol and Phosphate buffer (0.02M, pH-3.6) in the ratio of 40:60% v/v. The separation was achieved on an Inertsil C18 ODS (4.6mm × 250mm) 5µm particle size column using isocratic mode. Drug peak were well separated and were detected by a UV detector at 246 nm. The retention time of Elinzanetant was found to be 5.462minutes. The method was linear at the concentration range 6–14 μg/ml for Elinzanetant. The method has been validated according to ICH guidelines with respect to system suitability, specificity, precision, accuracy and robustness. Elinzanetant limit of detection (LOD) and limit of quantification (LOQ) were 0.487μg/ml and 1.477μg/ml respectively. Keywords: Elinzanetant, RP-HPLC, Accuracy, Precision, Robustness, ICH Guidelines.