A Review on Method Developed for the Estimation of Lasmiditan Hemisuccinate and Propranolol HCl

The present study describes the development and validation of a robust reverse‑phase high‑performance liquid chromatography (RP‑HPLC) method for the simultaneous estimation of Lasmiditan Hemisuccinate and Propranolol Hydrochloride in synthetic mixtures. Lasmiditan, a selective serotonin 5‑HT1F receptor agonist, is a novel anti‑migraine agent, while Propranolol, a non‑selective β‑adrenergic blocker, is widely prescribed for cardiovascular disorders and migraine prophylaxis. Their combined therapeutic potential necessitates a reliable analytical method to ensure accurate quantification in pharmaceutical formulations and synthetic mixtures. Method development involved systematic optimisation of chromatographic parameters, including mobile phase composition, column selection, detection wavelength, and flow rate. A C18 column (250 mm × 4.6 mm, 5 µm) was employed with a mobile phase consisting of phosphate buffer (pH 3.5) and acetonitrile in a 60:40 v/v ratio. The flow rate was maintained at 1.0 mL/min, with detection wavelengths set at 230 nm for Lasmiditan and 270 nm for Propranolol. Sample preparation included dissolution in methanol, sonication, and filtration through a 0.45 µm membrane. The method achieved baseline separation within 10 minutes, with sharp, symmetrical peaks and reproducible retention times. Validation was performed in accordance with ICH Q2(R2) guidelines. Linearity was established across 5–50 µg/mL for Lasmiditan and 5–100 µg/mL for Propranolol, with correlation coefficients exceeding 0.999. Accuracy was confirmed through recovery studies at 80%, 100%, and 120% levels, yielding recoveries between 98–102%. Precision was demonstrated with intra‑day and inter‑day %RSD values below 2%. Sensitivity was evident with LOD values of 0.5 µg/mL for Lasmiditan and 0.3 µg/mL for Propranolol, and LOQ values of 1.5 µg/mL and 1.0 µg/mL respectively. Robustness testing under deliberate variations in mobile phase composition, flow rate, and detection wavelength revealed no significant deviations. Specificity was validated by analysing blank, placebo, and spiked samples, with no interfering peaks observed. Stability studies confirmed that both drugs remained stable for at least 24 hours under ambient conditions. The developed RP‑HPLC method is simple, precise, accurate, and reproducible, making it suitable for routine quality control, formulation development, and stability testing. Its successful validation supports broader applications in pharmacokinetic studies and regulatory submissions, while future adaptations may include LC‑MS/MS coupling and green chromatography approaches.