Liquid Chromatographic Determination of Rutin and Ascorbic Acid-Binary Mixture in Pharmaceutical Preparations

Abstract

A liquid chromatographic procedure for the separation and determination of rutin and ascorbic acid in oral dosage forms is described. The dosage content of tablets and soft gelatin capsules is diluted and chromatographed on a Lichrosorb (C₁₈) column with a mobile phase of wat er∼methanol (55–45 V/V) and detection at 250 nm. Phenacetin was used as internal standard. The calibration is linear with correlation coefficient of 0.9999 for each component. Recoveries of spicked excipients averaged 99.5% and 99.2% for rutin and 100.2% and 99.8% for ascorbic acid in tablets and soft gelatin capsules, respectively. The method met USP XXII requirements for system suitability with proper resolution between two adjacent peaks. The relative standard deviation (RSD) of peak response of each component (obtained by chromatographing five replicates of standard solution) is less than 2% and tailing factor of each component is not greater than 1.5. The method can be used for composite and content uniformity assay of rutin and ascorbic acid in tablets and soft gelatin capsules.