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The quantitative analysis of Mavacamten in bulk form was performed by developing and validating a simple, rapid, precise, and stability-indicating RP-HPLC method. The method worked well for chromatographic separation, with great peak resolution and the right amount of time for retention. Validation testing confirmed that the method is reliable, precise, and suitable for standard quality control analysis of Mavacamten in bulk medicine samples. A reverse-phase high-performance liquid chromatography (RP-HPLC) method was established for the analysis of Mavacamten utilizing a C18 column, with a mobile phase of acetonitrile and water in a 90:10 ratio, a flow rate of 1.0 mL/min, and detection at 268 nm. The approach demonstrated a retention time of approximately 5.3 minutes with methanol utilized as the diluent for sample processing. The system suitability metrics, including theoretical plates, tailing factor, and %RSD, were within acceptable limits. The method was verified in accordance with ICH recommendations for specificity, linearity (2–12 µg/mL), accuracy, robustness, limit of detection (LOD), and limit of quantification (LOQ). The ICH guidelines were used to check the RP-HPLC method for Mavacamten. Specificity testing showed that the blank did not affect the drug's retention time. Precision investigations (system, technique, and intermediate precision) showed %RSD values around 2%, which means that the results were quite consistent. The method showed linearity between 2 and 12 ppm with r² = 0.9988. Robustness tests showed that the method was not influenced by small changes in flow rate and injection volume. The limits of detection (LOD) and quantification (LOQ) were found to be 0.24 ppm and 0.72 ppm, respectively, which shows that the method is very sensitive.

KEYWORDS

HPLC method development, Sotagliflozin.