1Department of Chemistry, Institute of Science, GITAM University, Visakhapatnam 530045, (Andhra Pradesh), India
*Corresponding author: Anjali Jha, Department of Chemistry, Institute of Science, GITAM University, Visakhapatnam 530045, (Andhra Pradesh), India. Email: ajhamani@gitam.edu
Received: 16th Dec, 2025; Revised: 8th Feb 2026; Accepted: 12th Feb, 2026; Available Online: 28th Feb, 2026
A sensitive, selective, and stability-indicating LC-MS/MS method was proposed for the quantification of lenalidomide impurity A in pharmaceutical matrices. Chromatographic separation was achieved on C18 column using a gradient elution of ammonium formate buffer (0.01 M) and acetonitrile at 0.5 mL/min with 20 min run time. Detection was performed in positive electrospray ionization (ESI) mode using multiple reaction monitoring (MRM) of the transition m/z 290.3437 ([M+H]⁺) → 70.1137 ([M+H]⁺). The method demonstrates excellent sensitivity with a limit of detection (LOD) of 1.99 ppm (0.0002%) and a limit of quantification (LOQ) of 6.05 ppm (0.0006%). Linearity was plotted from LOQ to 200% (120 ppm) of the specification level with a correlation coefficient ≥0.999. Accuracy studies prove the recoveries within 99.9–109.6% across LOQ, 50%, 100%, 150%, and 200% levels confirms minimal matrix interference. Precision, robustness, and ruggedness test yields %RSD values of below 2.0% under all tested conditions demonstrates high reproducibility and method reliability. Solution stability studies confirm that both standard and sample solutions were stable for at least 24 h, with cumulative %RSD values ≤1.8%. The as-such formulation display no detectable impurity A whereas spiked formulations display well-resolved peaks with acceptable recoveries. In summary, the validated LC-MS/MS method was consistent, reliable, and highly reproducible and offers superior selectivity and sensitivity compared to previously reported methods. This method has the ability to quantify lenalidomide impurity A at trace levels and makes this method well suited for routine quality control, stability testing, and regulatory impurity monitoring of lenalidomide pharmaceutical products.
Keywords: Impurity A of lenalidomide, LC-MS/MS Method, method validation, solution stability
How to cite this article: Jha A, Sista VSSK, Development and Validation of A Consistent, Reliable, And Reproducible Lc-Ms/Ms Method For The Determination Of Lenalidomide Impurity A In Pharmaceutical Matrices. Int J Drug Deliv Technol. 2026; 16(2): 442-451; DOI: 10.25258/ijddt.16.2.49
Source of support: Nil.
Conflict of interest: None