Development and validation of stability indicating RP-LC method for estimation of calcium dobesilate in pharmaceutical formulations

Research Article

Kalpana Nekkala, V. Shanmukha

Abstract

A new, simple, rapid, selective, precise and accurate isocratic reverse phase high performance liquid Chromatography assay method has been developed for estimation of Calcium dobesilate in tablet formulations. The separation was achieved by using column Waters symmetry C18 (4.6x150mm), 5μ (Make: Waters), in mobile phase consisted of pH 2.5 Phosphate buffer Acetonitrile and in the ratio of (95:5, v/v). The flow rate was 1.0 mL.min-1 and column oven temperature 30°C, the injection volume was 20 μL the separated Calcium dobesilate was detected using UV detector at the wavelength of 300 nm. The retention time of Calcium dobesilate, was noted to be 4.22 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.

Relevant Publications in Der Pharmacia Lettre