ANALYSIS OF DOFETILIDE IN BULK AND FORMULATIONS BY VALIDATED SPECTROFLUORIMETRIC METHOD
Sangeetha R. K.*, Sangeetha V., Sree Varshini S., Sowmiya S. and Ravi T. K.
ABSTRACT
The selected drug dofetilide do not have any native fluorescence. The structure contains tertiary amide with a oxide group in the aliphatic chain attached with the benzene ring. Hence an attempt was made to convert the compound into a fluorescence emitting moiety by treating with chromotropic acid in the presence of sulphuric acid at a temperature of 100ᵒC. The drug was treated with 0.25 ml of sulphuric acid and 1 ml of 0.01% chromotropic acid and placed on a thermostat maintained at a temperature of 100ᵒC for 15 minutes. The chemistry of the reaction involves the breakage of the aliphatic chain oxide group. The second step involves the attachment of the chromotropic acid resulting in the formation of fluorescence compound. The fluorescence product formed was measured in the UV Visible region. The excitation was found at 359 nm and emission at 707 nm. The linearity was found between 0.25 to 1.5 mcg/ml with a correlation coefficient of > 0.99. The percentage RSD value for the precision studies and accuracy was less than 2. The method developed was validated according to the ICH guidelines and can be applied for the routine analysis of dofetilide in bulk drugs and formulations.
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