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Abstract

DEVELOPMENT AND VALIDATION OF RP-LC METHOD FOR DAPSONE IN PHARMACEUTICAL FORMULATIONS

T. Benjamin* and Dr. D. Ramachandran

ABSTRACT

A new, simple, rapid, selective, precise and accurate isocratic reverse phase high performance liquid Chromatography assay method has been developed for estimation of Dapsone in tablet formulations. The separation was achieved by using column YMC pack ODS AQ C18 (150×4.6mm, 3μm), in mobile phase consisted of acetonitrile and pH 4.5 ammonium acetate buffer, adjusted to pH 4.5 with the help of dilute acetic acid in the ratio of (75:25, v/v). The flow rate was 1.0 mL/min-1 and the separated Dapsone was detected using UV detector at the wavelength of 254 nm. Column temperature 25°C and sample temperature ambient and injection volume 10μl. The retention time of Dapsone, was noted to be 7.05 min respectively, indicative of rather shorter analysis time. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent.

Keywords: Liquid Chromatography; Dapsone, Validation.


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