Development and Validation of Amlodipine Impurities in Amlodipine Tablets Using Design Space Computer Modeling
Development and Validation of Amlodipine Impurities in Amlodipine Tablets Using Design Space Computer Modeling作者机构：Department of Chemistry K.L. University Vaddeswaram India
出 版 物：《American Journal of Analytical Chemistry》 (美国分析化学（英文）)
年 卷 期：2016年第7卷第12期
页 面：918-926页
学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学]
主 题：HPLC LOQ QbD Reporting Threshold
摘 要：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.
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