TITLE:
Development and Validation of Amlodipine Impurities in Amlodipine Tablets Using Design Space Computer Modeling
AUTHORS:
Chamarthi R. P. Kishore, G. V. Krishna Mohan
KEYWORDS:
HPLC, LOQ, QbD, Reporting Threshold
JOURNAL NAME:
American Journal of Analytical Chemistry,
Vol.7 No.12,
December
28,
2016
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 3μ 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.