Abstract:
OBJECTIVE To establish a method for determination of the related substances of calcium pantothenate by HPLC. METHODS A C18 column was used. The mobile phase was phosphate buffer solution composed of 8.34 g KH
2PO
4 and 0.87 g K
2HPO
4 in 1 000 mL water which pH was 5.7 adjusted by phosphoric acid. The wavelength was 205 nm. RESULTS The resolution of calcium pantothenate and relate substances was good. The limit of detection of pantoic acid which was the special impurity was 1.33 ng, and the limit of quantitation of it was 4.42 ng. The related substances of three batches of calcium pantothenate were detected, and the contents of the pantoic acid were 0.234%, 0.222% and 0.234%, and the contents of other related substances were 0.168%, 0.165% and 0.157%. CONCLUSION The method is accurate and reliable, and could be applied to determine the related substances of calcium pantothenate.