Validation of Paliperidone by Non-Aqueous Potentiometric Titration Method for Quantitative Determination from Active Pharmaceutical Ingredient and Formulation

摘要

A sensitive and simple potentiometric titration method by using non-aqueous solvent was described for quantification of paliperidone from active pharmaceutical ingredient and formulation. The method was carried out by using standard 0.1 N perchloric acid as titrant for quantification. A % RSD value is 0.1565 indicated precision of method. The linearity (r2 > 0.9999) was obtained in the range 0.02 mg to 0.100 mg of paliperidone weight. The percentage recovery of paliperidone was found between 99.60% to 100.13%. The ruggedness was checked with different analysts, chemicals and different manufactures of auto-titrators.