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For various types of drug approval processes like INDs, NDAs, ANDAs, veterinary drug approval, the data related to bioanalytical method development and validation is needed to sponsors. Various agencies namely US FDA, American association of pharmaceutical scientists (AAPS), Health protection Branch (HPB), Association of analytical chemists (AOAC), Center for Veterinary Medicine (CVM), U.S. Department of Health and Human Services Food and drug Administration, Center for Drug Evaluation and Research (CDER), European Medicine Agency (EMA), China Food and Drug administration(CFDA), European Bioanalytical Forum (EBF), Global CRO council (GCC), ANVISA (Brazil), Japan Bioanalytical Forum (JBF) had done collective efforts at different timings to regulate and harmonize bioanalytical method development and validation.

The synthesis, characterization and quantitation of process related impurity diethyl 4-(3-chlorophenyl)-2, 6-dimethyl-1, 4-dihydropyridine-3, 5-dicarboxylate from amlodipine bulk and Tablet formulations. The scheme was performed by using Hantzch pyridine synthesis. The impurity was recrystallized and preliminary evaluation was done on lab scale viz. Melting point, TLC and elemental analysis. The melting point of impurity was found to be 158-160 0 C. The TLC of impurity was carried out by using benzene: pyridine: methanol in the ratio of 5:3:2 was selected as mobile phase for quantification of impurity. The Rf value of the impurity was found to be 0.80. The conformation of synthesized Amlodipine impurity was carried out by using sophisticated instrument such as, FT-IR, NMR, GC-MS, and RP-HPLC method was developed to identify and quantify the Amlodipine impurity in bulk and formulation as per ICH Q2B guidelines. The method was found to be linear, precise, accurate, robust and rugged. Finally diethyl 4-(3-chlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate impurity synthesized and quantified from amlodipine bulk and Tablet formulations. Quantization of process related impurity of amlodipine in bulk and tablets was carried out. Impurity was found in bulk and in tablet I and II it was found to be 0.215%, 0.276%.and 0.323% respectively. As per the ICH limit the amount of impurity is more than 0.1% indicates that the impurity found in bulk and tablet formulations is potential impurity.

Impurities are nothing but the unidentified, unintended substance present along with desired substance. The newer regulations of US FDA, MHRA intends for the requirements of impurities rather than purity of pharmaceuticals. The impurity profiling of pharmaceuticals can be done by using various analytical methods like UV, HPLC, LC-MS, GC-MS, SCFC etc. Mostly RP-HPLC method commonly adopted for the qualification as well as quantification of impurities. The present review is an attempt made in the respect of highlighting the some important methods, quality guidelines and applications of impurity profiling.