Simultaneous Determination of Main Components and the Related Substance ?-aminobutyric Acid in Al-endronate Tablets by Pre-column Derivatization HPLC / 中国药房

ABSTRACT

OBJECTIVE: To develop a pre-column derivatization HPLC method for the simultaneous determination of the contents of alendronate and the related substance ?-aminobutyric acid in alendronate tablets.METHODS: After AccQ pre-column derivatization,the sample was determined with Diamonsil C18 column used as stationary phase and acetonitrile-35 mmol?L-1 acetate buffer solution(13.5∶86.5,V/V) as a mobile phase.The flow rate was 0.7 mL?min-1 and the column temperature was set at 35 ℃.RESULTS: Alendronate and ?-aminobutyric acid were well-separated and able to be determined simultaneously,with their linear ranges at 30.9～990 ?g?mL-1(r=0.999 6) and 0.307～960 ?g?mL-1(r=0.999 9),respectively and their average recovery rates at 99.3～100.8% and 99.3～100.2%,respectively.The intra-day RSDs of both were no more than 0.8% and their inter-day RSDs were no more than 1.9%.CONCLUSIONS: The method is simple,selective and suitable for the determination of alendronate and the related substance ?-aminobutyric acid of alendronate tablets.