Development and Validation of Amlodipine Impurities in Amlodipine Tablets Using Design Space Computer Modeling

Abstract

A rapid, sensitive, robust, rugged and linear HPLC method is developed using QbD approach and validated as per ICH for the estimation of amlodipine impurities in tablet dosage form. Phosphate buffer with triethyl amine adjusted to pH to 2.8 is used as the mobile phase and 3 µ particle size C18 column of 150 mm length and 4.6 mm internal diameter is used. Using photo diode array (PDA) detector, the compounds are monitored at 340 nm. All impurities are well separated and flow Gradient has been optimized to obtain the acceptable resolution between impurities and amlodipine. Diluent was chosen, based on the impurity peak shapes and recoveries. Test concentration and injection volume have been optimized to obtain limit of quantification (LOQ) values below the reporting threshold.