A Comprehensive Review on Drug Profile of Benralizumab

A simple, Précised, Accurate method was developed for the estimation of Lasmiditan by RP-HPLC technique. Chromatographic conditions used are stationary phase Agilent 150mm x 4.6 mm, 5m ,Mobile phase Acetonitrile : Water in the ratio of 50:50 and flow rate was maintained at 1ml/min, detection wave length was 260nm, column temperature was set to 30oC and diluent 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% to150 % levels, R2 value was found to be as 0.999. Precision was found to be 0.8 for repeatability and 0.9 for intermediate precision.LOD and LOQ are 0.13µg/ml and 0.40µg/ml respectively. By using above method assay of marketed formulation was carried out 99.58% was present. Degradation studies of Lasmiditan were done, in all conditions purity threshold was more than purity angle and within the acceptable range. Full length method was not performed; if it is done this method can be used for routine analysis of Lasmiditan.

Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2025-03-11
DOI
https://doi.org/10.5281/zenodo.15003789
Primary Topic
Analytical Methods in Pharmaceuticals
Type
article
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A Comprehensive Review on Drug Profile of Benralizumab

Zenodo (CERN European Organization for Nuclear Research)
Analytical Methods in Pharmaceuticals
article

A Comprehensive Review on Drug Profile of Benralizumab

article en

Abstract

A simple, Précised, Accurate method was developed for the estimation of Lasmiditan by RP-HPLC technique. Chromatographic conditions used are stationary phase Agilent 150mm x 4.6 mm, 5m ,Mobile phase Acetonitrile : Water in the ratio of 50:50 and flow rate was maintained at 1ml/min, detection wave length was 260nm, column temperature was set to 30oC and diluent 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% to150 % levels, R2 value was found to be as 0.999. Precision was found to be 0.8 for repeatability and 0.9 for intermediate precision.LOD and LOQ are 0.13µg/ml and 0.40µg/ml respectively. By using above method assay of marketed formulation was carried out 99.58% was present. Degradation studies of Lasmiditan were done, in all conditions purity threshold was more than purity angle and within the acceptable range. Full length method was not performed; if it is done this method can be used for routine analysis of Lasmiditan.

Zenodo (CERN European Organization for Nuclear Research)
Clean water and sanitation
Openalex Percentile: Top 52%
Analytical Methods in Pharmaceuticals
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