Importance of a rapid and accurate UPLC method for in-vitro dissolution testing of a narrow therapeutical index molecule

摘要

A rapid, accurate and precise Ultra Performance Liquid Chromatographic (UPLC) method was developed for generating an exhaustive In-Vitro Dissolution profiles of phenytoin sodium capsules in an Immediate Release formulations. The method has been validated. The method employs Waters UPLC system on Acquity BEH C18, 100 x 2.1mm, 1.7μm column with a flow rate of 0.3 mL/min using a mobile phase of 50-50% of Buffer and Acetonitrile. The UPLC was equipped with a UV-Visible Detector and the measurements were taken at 229nm. The immediate release formulations label claim were 300mg, 100mg, 50mg and 25mg for which the injection volume was appropriately selected. The total runtime for each injection was 2mins only with the retention time of the phenytoin peak at about 1.4mins.The method was validated for Linearity, Specificity, precision, Solution Stability and Accuracy. The method validation shows the linearity correlation 0.999. The intra and inter-day precision are within acceptance criteria. Phenytoin sodium dissolution shows the stability of sample and standard solution. The accuracy was within Limit and data was generated for In-vitro Dissolution studies of phenytoin sodium capsules and Tablets.