STABILITY INDICATING LC–ESI-MS/MS METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATION OF LURBINECTEDIN IN BIOLOGICAL MATRICES

MANTRAVADI ANUSHA; RAMREDDY GODELA; KUMAR SHIVA GUBBIYAPPA

doi:10.22159/ijap.2025v17i5.53562

Authors

MANTRAVADI ANUSHA Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM Deemed to be Univeristy, Rudraram, Patancheru, Telangana, India
RAMREDDY GODELA Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM Deemed to be Univeristy, Rudraram, Patancheru, Telangana, India https://orcid.org/0000-0003-4334-7162
KUMAR SHIVA GUBBIYAPPA Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM Deemed to be Univeristy, Rudraram, Patancheru, Telangana, India

DOI:

https://doi.org/10.22159/ijap.2025v17i5.53562

Keywords:

Lurbinectedin, LC-ESI-MS/MS, Bioanalytical method, precision, Sensitivity, Zorbax SB-C18 column

Abstract

Objective: A new and validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and used for the quantitative analysis of the anticancer drug Lurbinectedin in plasma samples.

Methods: Liquid-liquid extraction method was used to extract the Lurbinectedin from plasma, and Ledipasvir was used as an internal standard (IS), Chromatographic separation of Lurbinectedin was accomplished with Zorbax SB-C18 column (250 mm×4.6 mm, 5 µm) using a mobile phase comprises of 0.1% v/v formic acid and acetonitrile (10:90, v/v) pumped at a flow rate of 0.80 ml/min. The total run time for Lurbinectedin and internal standard elution was 3.5 min. The linearity was attained for a concentration range of 1.50–5000 ng/ml with a correlation coefficient (r²) of 0.9994 by the optimized method. The lower limit of quantification (LLOQ) was established at 1.50 ng/ml, which resembles the sensitivity of the method toward Lurbinectedin.

Results: The method showed high accuracy, ranging from 95.31% to 104.06% of nominal values, with intra-and inter-day precision within a 4.32% coefficient of variance (%CV). Matrix effects at the low-quality control (LQC) level varied between 94.25% and 104.85% (%CV: 4.61), while at the high-quality control (HQC) level, they ranged from 94.62% to 103.88% (%CV: 4.02). The mean recovery across all control standards was 95.58%.

Conclusion: Stability assessments confirmed the robustness of the method. The developed LC-MS/MS approach is reliable for routine bioanalytical applications, including quality control, pharmacokinetic studies, and bioequivalence assessments of Lurbinectedin in biological matrices.

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