Abstract

For the quantitative analysis of Ensitrelvir in bulk and pharmaceutical formulations, a simple, accurate, and dependable reverse-phase high-performance liquid chromatography (RP-HPLC) technique was effectively created and validated. Retention time was around 9.6 minutes using a chromatographic separation with a PLATISIL C18-EP column and a mobile phase of acetonitrile and triethylamine buffer (pH 4.0) in a 60:40 ratio. The approach showed appropriate system appropriateness criteria, including a tailing factor of 1.28 and a theoretical plate count of ~4883, therefore verifying effective separation and peak symmetry. Performed in compliance to ICH criteria, validation investigations revealed great linearity (20â??100 µg/mL, R² = 0.999), high precision (RSD < 2%), and accuracy with recovery levels ranging from 98â??102%. Sensitivity was demonstrated with LOD and LOQ levels of 0.1 µg/mL and 0.38 µg/mL, respectively. Robustness studies showed that small changes in chromatographic settings had little impact on method performance. All in all, the created RP-HPLC technique is appropriate for routine quality control analysis of Ensitrelvir in bulk and pharmaceutical formulations since it is accurate, exact, sensitive, strong, and reproducible.

Author(s): Archana Terala*, Bandi Shravani, Neerudi Bhuvana, Chinnamatam Sowjanya, Sameera Begum

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