LC/MS/MS Method Development and Validation for the Estimation of Lasmiditan in Bulk and Pharmaceutical Formulation

Abstract

Background: Lasmiditan is an agonist of 5HT1F receptor, acute migraine is treated and oral dose is safe and effective. No analytical methods were reported on Lasmiditan Drug. Objectives: The goal of the current project is to create a quick, effective, and reproducible LC/MS/MS method for the estimation of Lasmiditan. The mobile phase was used Acetonitrile: 0.1% formic acid (70:30) in the developed method, and it was running down a C18 column (SP) with dimensions of 150 mm, 4.6 mm i.d., and 3.5 µm at a rate of 1 mL/min. The [M+H]+ ion m/z ratio for the substance was observed in the mass spectrum was 378.24. The drug had a retention time of 2.3 minutes. The linearity range was found to be in between 12.50 ng/mL and 75 ng/mL. The regression coefficient value was found to be 0.999, which is good satisfactory value for linearity. The LOD and LOQ for baseline measurement and detection were 0.66 ng/mL and 2.22 ng/mL, respectively; the method was shown good accuracy and precision levels, and it was proved through the assay values. The method was proved as robust after deliberated changes in parameters of flow rate (±0.2mL) and organic phase (±3 mL) in mobile phase composition and values were found to be 99.50%-100.73% & 99.10%- 101.83% respectively. Conclusion: The LC/MS/MS method is more advanced and sensitive to determine the drugs at nanograms level. Hence developed method used for the regular assay. This is more sensitive, selective, and rapid for identification and quantification of LMT in the bulk and Pharmaceutical formulation.