Abstract

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

Kalka Verma*, Bhushan Korde, B. K. Dubey, Deepak Kumar Basedia, Prabhat Kumar Jain, Sunil Saha and Vivek Singh Thakur

ABSTRACT

A new Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the quantification of Lasmiditan in synthetic pharmaceutical formulations. The method utilized isocratic conditions with a mobile phase comprising 15 mM potassium dihydrogen phosphate (KH₂PO₄) and methanol in a 15:85 v/v ratio, using a ThermoC-18 column (4.6 × 250 mm, 5 μm particle size) and detection at 258 nm. System suitability tests demonstrated that the method met the required criteria for accuracy and precision, with theoretical plates (3266.667), tailing factor (1.19), and retention time (5.117 minutes) within acceptable limits. The method showed excellent linearity (r² = 0.9993) within the concentration range of 5-25 μg/ml. Specificity tests confirmed no interference from plasma, excipients, or other formulation components. Recovery studies at 80%, 100%, and 120% concentrations revealed high accuracy, with recoveryrates close to 100% and low relative standard deviation (%RSD) values. Precision tests yielded consistent results, with SD and %RSD values below 2%, indicating reliable repeatability. Robustness studies confirmed the method's resilience to small variations in chromatographic conditions. The method demonstrated good sensitivity with a Limit of Detection (LOD) of 0.65 μg/ml and a Limit of Quantification (LOQ) of 1.85 μg/ml. Assay of synthetic mixtures showed high accuracy, with results close to the label claim, further supporting the method’s reliability. Forced degradation studies highlighted the stability of Lasmiditan under various stress conditions, revealing stability under standard conditions and degradation under acidic, alkaline, and photolytic stress, while remaining stable under oxidative conditions. In conclusion, the developed and validated RP-HPLC method for Lasmiditan is accurate, precise, robust, and sensitive, making it a suitable tool for the quantitative analysis of Lasmiditan in pharmaceutical formulations. This method is well-suited for quality control, ensuring both the drug's efficacy and stability during formulation and storage.

Keywords: RP-HPLC, Lasmiditan, Validation, Linearity, Recovery Studies, Precision. Specificity, Forced Degradation.