Eudragit® L100 is a commonly used polymer in a coating layer of modified-release drug\nformulation to prevent drug release in the stomach. The amount of Eudragit® L100 in the formula\ndetermines the dissolution profile of drug at its release medium. Hence, its quantification in reference\nproduct will facilitate the formulation of a bioequivalent drug product. Some analytical methods\nincluding size-exclusion chromatography (SEC) have been reported for characterization of Eudragit®\nL100 either as single component or its conjugate with the enzyme, but none for its quantification\nin drug formulation. In this work, an SEC method with charged-aerosol detection (CAD) was\ndeveloped for determination of Eudragit® L100 in an enteric-coated tablet formulation using Waters\nUltrahydrogel 1000 andWaters Ultrahydrogel 120 columns in series. The mobile phase was a mixture\nof 90:10 (v/v) 44.75 mM aqueous ammonium acetate buffer, pH 6.6 and acetonitrile pumped at\na constant flow rate of 0.8 mL/min in isocratic mode. The method was validated for specificity,\nworking range, limit of detection (LOD), limit of quantification (LOQ), accuracy and precision.\nThe method was shown to be specific for Eudragit® L100 against the diluent (mobile phase) and\nplacebo of a coating layer for the tablet. A good correlation coefficient (r = 0.9997) of CAD response\nagainst Eudragit® L100 concentration from 0.1â??1.0 mg/mL was obtained using polynomial regression.\nLOD and LOQ concentrations were 0.0015 and 0.0040 mg/mL, respectively. The mean recovery of\nEudragit® L100 was in the range of 88.0â??91.1% at three levels of working concentration: 50%, 100%\nand 150%. Six replicated preparations of samples showed good precision of the peak area with %\nrelative standard deviation (RSD) 2.7. In conclusion, the method was suitable for quantification of\nEudragit® L100 in an enteric-coated tablet formulation.
Loading....