International Journal of Drug Delivery Technology
Volume 15, Issue 3

Stability-Indicating RP-HPLC Method Development and Validation for the Estimation of Mirdametinib in Bulk and Pharmaceutical Dosage Form

Venkata Lakshamana Sagar Dantinapalli*, Meenakshi Sharma 

Department of Chemistry, Raffles University, Neemrana, Alwar, Rajasthan-301705, India 

Received: 18th May, 2025; Revised: 24th Jul, 2025; Accepted: 19th Aug, 2025; Available Online: 25th Sep, 2025 

ABSTRACT

A novel, stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantitative estimation of Mirdametinib in bulk and pharmaceutical dosage forms. The chromatographic separation was achieved on an Agilent Eclipse XDB C18 column (150 × 4.6 mm, 3.5 µm) using an isocratic mobile phase comprising acetonitrile and 0.1% formic acid (30:70 v/v). Detection was performed at 223 nm with a flow rate of 1 mL/min and an injection volume of 10 µL. The method was validated in accordance with ICH Q2(R1) guidelines, confirming its specificity, precision, linearity, accuracy, robustness, and sensitivity. Linearity was demonstrated across the concentration range of 25–150 µg/mL with a correlation coefficient (R²) of 0.99979. The system and method precision showed %RSD values below 2.0, while recovery studies confirmed accuracy with values between 99.8% and 100.5%. The limit of detection (LOD) and quantification (LOQ) were 0.60 µg/mL and 2.0 µg/mL, respectively. Robustness studies confirmed the method's reliability under slight variations in chromatographic conditions. Forced degradation studies under acidic, basic, oxidative, thermal, photolytic, and hydrolytic stress conditions demonstrated the method’s capacity to differentiate Mirdametinib from its degradation products. The developed method was successfully applied to the assay of a marketed formulation (GOMEKLI), showing a 99.8% assay value. Overall, the validated RP-HPLC method offers a reliable and precise analytical tool for routine quality control of Mirdametinib.

Keywords: Mirdametinib, RP-HPLC, Method Validation, Forced Degradation, Stability-Indicating Method, Pharmaceutical Dosage Form

How to cite this article: Venkata Lakshamana Sagar Dantinapalli, Meenakshi Sharma. Stability-Indicating RP-HPLC Method Development and Validation for the Estimation of Mirdametinib in Bulk and Pharmaceutical Dosage Form. International Journal of Drug Delivery Technology. 2025;15(3):1109-13. doi: 10.25258/ijddt.15.3.28

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