Spectroscopic Method Development and Validation for Lasmiditan Quantification in Bulk and its Tablet Formulations

Syed Imam Pasha^1* and Anupama Koneru²

¹Department of Pharmaceutical Quality Assurance, Sultan-ul-Uloom College of Pharmacy Mount Pleasant, Banjara Hills, Hyderabad, Telangana, India.

²Department of Pharmacology, Sultan-ul-Uloom College of Pharmacy Mount Pleasant, Banjara Hills, Hyderabad, Telangana, India.

Corresponding Author E-mail: impazam@gmail.com

DOI : http://dx.doi.org/10.13005/bbra/3278

ABSTRACT: A simpler, economical visible spectroscopic procedure for determining the value of Lasmiditan in bulk active pharmaceutical ingredients and its formulation is developed. It is used in the acute treatment of migraines. Lasmiditan helps reduce the risk of vasoconstriction, making Lasmiditan a suitable option for patients with cardiovascular conditions. The absorption maximum was found to be 626 nm. As per Beer Lambert’s law, the linearity was in the 10-50 µg/ml concentration range. Validation parameters such as Molar absorptivity, Accuracy, Precision, and Sandal’s sensitivity were within the regulated limits. The Percentage Relative Standard Deviation was less than 10% and the average recovery was 98%. This quantitative analytical method is used in quality control laboratories, bulk drugs, and formulation industries.

KEYWORDS: Bulk Drug; Estimation; Formulation; Lasmiditan; Spectroscopy

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