Determination of the related substances of atorvastatin calcium and intermediate L1 by HPLC

To investigate the related substances of atorvastatin calcium(ATV-Ca)and it′s key intermediate L1, 14 related substances were synthesized, and an HPLC method was developed by using a C₁₈ column, the mobile phase of H₂O-CH₃CN-THF-MeOH(36 ∶8. 4 ∶29 ∶26. 6), and the detection wavelength of 246 nm. There were 4 potential impurities in intermediate L1 and 10 potential impurities in ATV-Ca; The established methods were accurate and reproducible, which could be used for analysing the related substances in atorvastatin calcium and its key intermediate L1.