Abstract

HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF LASMIDITAN IN MARKETED FORMULATION

Harshali Solanki*, Ritesh Agrawal, Sarita Karole and Kavita R. Loksh

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Abstract

A reliable, accurate and simple RP-HPLC method was developed for the simultaneous estimation of Lasmiditan, validated according to ICH guidelines in tablet dosage form. A column of inertsil ODS (150x4.6mm, 3.5μm) with a flow rate of 1ml/min was used. The combination of 0.1% ortho phosphoric acid and Acetonitrile in 50:50 ratio was used as a mobile phase. Lasmiditan peak was eluted at a retention time of 3.203 min. The total run time was 5min. Standard solutions were prepared by dissolving in acetonitrile first and then make up to the mark with mobile phase. The method shows a good linearity in the concentration range of 5-75μg/ml of Lasmiditan with correlation coefficient 0.999. This method was validated in terms of specificity, linearity, accuracy, LOD, LOQ, robustness and forced degradation.

Keywords: RP-HPLC, Development, Validation, Lasmiditan.