Development and Validation of Amlodipine Impurities in Amlodipine Tablets Using Design Space Computer ModelingReport as inadecuate




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A rapid, sensitive, robust, ruggedand linear HPLC method is developed using QbD approach and validated as per ICHfor the estimation of amlodipine impurities in tablet dosage form. Phosphatebuffer with triethyl amine adjusted to pH to 2.8 is used as the mobile phaseand 3μ particle size C18 column of 150 mm length and 4.6 mm internal diameteris used. Using photo diode array PDA detector, thecompounds are monitored at 340 nm. All impurities are well separated and flowGradient has been optimized to obtain the acceptable resolution betweenimpurities and amlodipine. Diluent was chosen, based on the impurity peak shapes and recoveries. Test concentration andinjection volume have been optimized to obtain limit of quantification LOQ values below the reporting threshold.

KEYWORDS

HPLC, LOQ, QbD, Reporting Threshold

Cite this paper

Kishore, C. and Mohan, G. 2016 Development and Validation of Amlodipine Impurities in Amlodipine Tablets Using Design Space Computer Modeling. American Journal of Analytical Chemistry, 7, 918-926. doi: 10.4236-ajac.2016.712078.





Author: Chamarthi R. P. Kishore*, G. V. Krishna Mohan

Source: http://www.scirp.org/



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