STABILITY INDICATING HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF DOFETILIDE IN MARKETED FORMULATION
Rachit Dubey
ABSTRACT
A simple, accurate, precise, and stability-indicating reverse phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the estimation of dofetilide in marketed capsule formulations. Chromatographic separation was achieved on a suitable C18 column using an optimized mobile phase under isocratic conditions, with detection carried out at an appropriate UV wavelength. The method showed excellent linearity over the concentration range of 5–25 µg/mL with a regression equation Y = 240.22x + 51.731 and a correlation coefficient (r² = 0.9998). The developed method was validated as per ICH Q2(R1) guidelines for specificity, accuracy, precision, robustness, and system suitability. Accuracy studies demonstrated mean percentage recoveries ranging from 97.83% to 99.33%, while precision studies revealed %RSD values below 2%, indicating good repeatability and intermediate precision. Robustness testing confirmed that small deliberate variations in chromatographic conditions did not significantly affect method performance. The assay of marketed capsule formulation showed 96.00% of the labeled claim. Forced degradation studies under acidic, alkaline, oxidative, thermal, and photolytic conditions confirmed that the method could effectively separate dofetilide from its degradation products, thereby establishing its stability-indicating nature. The proposed RP-HPLC method is suitable for routine quality control analysis and stability testing of dofetilide in bulk and pharmaceutical dosage forms.
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