Authors
Pratibha Atul Daroi, Pranjali Patil, Vijay Munipalli, Bhushan Sonawane
Published in
Turkish journal of pharmaceutical sciences. Volume 23. Issue 2. Pages 75-84. Sep 01, 2026.
Abstract
Mavacamten (MYK-461), approved for hypertrophic cardiomyopathy, is a cardiac myosin inhibitor. At present, no pharmacopoeial method for its quantification has been reported. Our study was designed to establish a validated stability-indicating reverse-phase high-performance liquid chromatography method to quantify MYK-461 in its capsule formulation.
For chromatographic separation, an Inertsil ODS-3V C18 column (250 × 4.6 mm, 5 μm) with the mobile phase of 0.1% trifluoroacetic acid and acetonitrile (50:50 v/v) was used. The flow rate (1.0 mL/min), column temperature (35 °C), injection volume (10 μL), total run time (10 minutes), and detection wavelength (269 nm) were applied.
The validated method showed precision, accuracy, and robustness, with relative standard deviation < 2% and recovery of 100.5%. Linearity was observed over the range 5-75 μg/mL (r = 0.9994). We achieved a clear, well-resolved separation of MYK-461 from impurities, with estimated limit of detection (1.58 μg/mL) and limit of quantification (4.8 μg/mL). In forced degradation studies, we observed the highest degradation under acidic conditions (10.37%), while minimal degradation under photolytic (0.93%), thermal (1.66 %), oxidative (2.56%), and alkaline (4.19%) conditions.
The developed method is precise and reliable, and offers a practical tool for routine quality control and future research, while emphasising the need for controlled storage conditions to ensure long-term drug integrity.
PMID:
42678189
Bibliographic data and abstract were imported from PubMed on 01 Sep 2026.
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