Determination of accessories lactose by HPLC-RID
10.7501/j.issn.1674-6376.2017.07.012
- VernacularTitle:HPLC-RID法测定辅料乳糖
- Author:
ning Xiao MA
1
;
da Hong LIU
;
Shuo ZHANG
;
Yan QI
;
Yan XUE
;
ying Hong WANG
Author Information
1. 辽宁远大诺康生物制药有限公司
- Keywords:
HPLC-RID;
lactose;
content determination
- From:
Drug Evaluation Research
2017;40(7):942-945
- CountryChina
- Language:Chinese
-
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 (70:30).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.
