Analytical RP-HPLC Method Development and Validation of Dapsone for Determination of Assay and Content Uniformity

The development of a simple, precise and accurate RP-HPLC method for the determination content uniformity of Dapsone in the pharmaceutical dosage form and the developed method was validated as per the ICH Q2 (R1) guidelines. A HPLC of Shimadzu (LC2010); C18 Column (4.6 X 250 mm, 5 μm) and the mobile phase of Acetonitrile: Water (65:35 v/v) was used for separation and quantification of Dapsone. Analyses were carried out by flow rate of 1.5 ml/min at the detection wavelength 254 nm. This method covers the linearity range of μg/ml with the correlation coefficient (r2) was 0.9991. The system suitability parameters were within the acceptable limits. The Limit of Detection (LOD) and Limit of Quantification (LOQ) were found to be 1.08μg/ml and 3.29μg/ml respectively. The mean % recovery was found to be 99.62%. The content uniformity of dapsone tablet is a 99.99%. It was concluded that the procedure is valid and can be applied for determination content uniformity of Dapsone in the tablet dosage forms.