Determination of accessories lactose by HPLC-RID / 药物评价研究

ABSTRACT

Objective To establish a method for determination of accessories lactose by HPLC-RID.Methods Boston Green Amino-NH2 column (250 mm× 4.6 mm,5 μm) was used.The mobile phase was acetonitrile-water (7030).The flow rate was 1.0 mL/min.The column temperature was 45 ℃,the detector temperature was 40 ℃ and the injection volume was 10 μL.Results Lactose showed good linearity in the range of 0.2-5.0 mg/mL (r≥0.999 8).The detection limit was 0.06 mg/mL.The average recovery was 99.6％ and the relative standard deviation was 0.7％.Conlusion The method is specific,convenient,fast and accurate,which can be used for determination of accessories lactose.