Development and Validation of Stability Indicating UV Spectroscopic Method for Estimation of Dapsone

Author(s): Santosh V. Gandhi* and Gaurav R. Patil

Abstract: A stability-indicating UV Spectrophotometric method has been developed for analysis of the Dapsone in the presence of the degradation products and is validated as per ICH Q2 R1 guidelines. Dapsone in methanol shows maximum absorbance at 295 nm. The data of linear regression analysis indicated a good linear relationship over the range of 2-20 μgml-1concentrations with a correlation coefficient (R2) of 0.984. The LOD and LOQ were found to be 0.066 μg ml-1 and 1.200 μg ml-1, respectively. Percentage assay of Dapsone tablets was found to be in the range of 98.36 - 101.49 %. Dapsone was subjected to different stress testing conditions. Degradation of Dapsone was mainly found in alkaline and acidic condition. The developed method was found to be simple, accurate and precise for analysis of Dapsone and can be adopted for routine analysis of drug in bulk and pharmaceutical dosage form.

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