Degradation Studies and Method Development and Validation of Lanadelumab Using UV Detector in RP-HPLC.

Authors

S Marakatham, Meruva Sathish Kumar, A Kavya, B Ramu, Prathibha Bharathi Mare

Published in

Zhongguo ying yong sheng li xue za zhi = Zhongguo yingyong shenglixue zazhi = Chinese journal of applied physiology. Volume 41. Pages e20250024. Oct 13, 2025. Epub Oct 13, 2025.

Abstract

The RP-HPLC methodology was used to establish a straightforward, accurate, and precise method for estimating Lanadelumab. The following chromatographic conditions were used: 5. Mobile phase: 0.1% OPA buffer: Acetonitrile in a ratio of 65:35; 5. Stationary phase: Agilent C18 250 x 4.6 mm; 5. Detection wavelength: 228.0 nm; column temperature: 30 °C; diluent: 50:50 acetonitrile: water; retention time: 2.280 min. As the most efficient approach, conditions were finalized. The standard was injected six times to study the system appropriateness characteristics, and the results fell well within the acceptable range. An analysis of linearity was conducted at 25% to 150% levels, and the R2 score was 0.999. Standard precision was determined to be 0.8, whereas repeatable precision was found to be 0.5. 0.08µg/ml is the LOD, while 0.24µg/ml is the LOQ. The assay of the marketed formulation was conducted using the described method, and 100.14% was found.

PMID:
41077475
Bibliographic data and abstract were imported from PubMed on 13 Oct 2025.

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