title: Spectroscopic characterization and quantitative determination of atorvastatin calcium impurities by novel HPLC method.
abstract: Seven process related impurities were identified by LC-MS in the atorvastatin calcium drug substance. These impurities were identified by LC-MS. The structure of impurities was confirmed by modern spectroscopic techniques like (1)H NMR and IR and physicochemical studies conducted by using synthesized authentic reference compounds. The synthesized reference samples of the impurity compounds were used for the quantitative HPLC determination. These impurities were detected by newly developed gradient, reverse phase high performance liquid chromatographic (HPLC) method. The system suitability of HPLC analysis established the validity of the separation. The analytical method was validated according to International Conference of Harmonization (ICH) with respect to specificity, precision, accuracy, linearity, robustness and stability of analytical solutions to demonstrate the power of newly developed HPLC method.
authors: Department of Chemistry, Zakir Husain College, University of Delhi, JLN-Marg, New Delhi 110 002, India. lokesh_kg@rediffmail.com
authors: Lokesh Kumar
authors: LK
authors: Gupta
mesh_terms: D000069059:Atorvastatin; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006538:Heptanoic Acids / Q000032:analysis* / Q000138:chemical synthesis / Q000737:chemistry; D009682:Magnetic Resonance Spectroscopy; D011758:Pyrroles / Q000032:analysis* / Q000138:chemical synthesis / Q000737:chemistry; D015203:Reproducibility of Results; D012996:Solutions; D013055:Spectrophotometry, Infrared
chemical_list: D006538:Heptanoic Acids; D011758:Pyrroles; D012996:Solutions; D000069059:Atorvastatin