DOI: 10.14704/nq.2022.20.8.NQ44746

Novel LC-MS Method for Quantification of Lefamulin in Plasma Samples

Dandamudi Santhoshi Priya, Shivakumar Gubbiyappa, Vasanthi Rangapuram

Abstract

The aim of present work is to develop cost effective, selective, precise and sensitive LC–MS method for the estimation of Lefamulin in rat plasma. The chromatographic separation of Lefamulin was successfully achieved with Zorbax Symmetry C18, (150mm x 4.6mm, 3.5µ) column and using mobile phase of 0.1%v/v formic acid: Acetonitrile (70:30 v/v) at a flow rate of 1 mL/min. The method was further validated to confirm the acceptability for pharmaceutical sector. The retention time of Lefamulin observed at 2.6min with the runtime of 4 min. The method was shown excellent linearity in the range of 1–20 ng/ml with R2 of 0.999. The % CV of peak areas Lefamulin of different level sample solution were shown ≤ 15% for repeated injection in precision and acuuercy. Matrix effect on analyte was very negligible with % mean accuracy of ±15%.There was no significant carry over observed during this experiment. All the samples under investigation were found to be free from interferences by the other substance in plasma sample at the retention time of drug. The array of stability studies, specifically, bench-top, freeze-thaw, short term and long-term stability was done to different concentration levels of biological samples, which were showing the % CV for peak response of repeated injections should be ≤15%. The approach created was highly simple, accurate, dependable, sensitive, and sturdy. The retention time requires less time and has a good sensitivity, making the approach suitable for routine analysis and bioanalysis.

Keywords

Lefamulin, LC-MS method, Sensitive, Matrix effect, stability studies

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