DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP- HPLC METHOD FOR QUANTIFICATION OF ERENUMAB IN ITS FORMULATIONS
*Parbati Kirtania, Yasmeen Baig and Dr. Anupama Konneru
A simple, Reversed Phase high-performance liquid chromatographic (RP-HPLC) technique has been developed and validated for the estimation of Erenumab. Chromatographic conditions used are stationary phase Kromasil C18 (250mm*4.6mm5m), Mobile phase Water: Methanol in the ratio of 40:60 and flow rate was maintained at 1.0ml/min, detection wavelength was 235nm, column temperature was set to 30D C and diluents was mobile phase Conditions were finalized as optimized method. System suitability parameters were studied by injecting the standard six times and results were well under the acceptance criteria. Linearity study was carried out between 25% to 150% levels, R 2 value was found to be as 0.999. Precision was found to be 0.8 for repeatability and 0.5 for intermediate precision. LOD and LOQ are 0.01μg/ml and 0.04μg/ml respectively. By using above method assay of pharmaceutical dosage form was carried out 100.36% was present. Degradation studies of Erenumab were done, in all condition’s the results obtained where within the acceptable range. this method can be used for routine analysis of Erenumab.
Keywords: RP- HPLC Erenumab, ICH Guidelines, validation.
[Full Text Article]