Spectroscopic characterization and quantitative determination of atorvastatin calcium impurities by novel HPLC method

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 1H 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.

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► Identification of possible impurities in atorvastatin calcium drug substance.
► Synthesis and spectroscopic characterization of atorvastatin related compounds.
► Development of single analytical method for quantitative determination with HPLC.
► Method validation, as per international pharmaceutical guidelines.