What question did this study set out to answer?

The aim is to develop and validate a reliable RP-HPLC method for estimating lasmiditan in tablet dosage forms.

January 17, 2026Open Access

Development and Validation of Stability Indicating RP-HPLC Method for the Estimation of Lasmiditan in tablet dosage form

Key Points

The aim is to develop and validate a reliable RP-HPLC method for estimating lasmiditan in tablet dosage forms.
Selection and optimization of mobile phase composition for HPLC.
Utilization of standard analytical guidelines from ICH and USP.
Validation of method based on criteria such as accuracy, precision, and robustness.
The method demonstrates high accuracy and reproducibility in measuring lasmiditan.
Validation confirms specificity and sensitivity for quality control applications.

Abstract

HPLC, in particular, offers high resolution, accuracy, and reproducibility, making it indispensable for routine quality control and advanced research applications. Method development in HPLC involves systematic selection and optimization of mobile phase composition, column chemistry, detection wavelength, and operational parameters to achieve reliable separation and quantification. Analytical method validation, guided by ICH and USP standards, ensures that developed methods meet essential criteria, including accuracy, precision, linearity, specificity, robustness, and sensitivity. Keywords: Lasmiditan, Development, RP-HPLC, Accuracy, linearity, Limit of detection (LOD) and Limit of quantification (LOQ).

Read Full Paperexternally

KI fragen

Bookmark

View Full Paper