Determination of the Related Substances in Plerixafor by HPLC
- VernacularTitle:HPLC法测定普乐沙福原料药的有关物质
- Author:
Lei WANG
;
Jialin WANG
;
Feng LI
- Publication Type:Journal Article
- Keywords:
Plerixafor;
Related substances;
HPLC
- From:
China Pharmacist
2016;19(10):1856-1858
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To develop a novel method for the determination of the related substances in plerixafor. Methods: A re-versed-phase ion-paired HPLC method was applied in the qualitative and quantitative determination of plerixafor by an external standard method. The method was performed on a Waters Xbridge C18 column (250 mm × 4. 6 mm, 5 μm), the mobile phase consisted of 1-heptanesulfonic acid sodium salt buffer (pH 2. 0) and acetonitrile with the ratio of 80 ∶20 (v/v), the flow rate was 1. 0 ml·min-1, the detection wavelength was 210 nm, the column temperature was 35℃, and the injection volume was 10 μl. Results:The degrada-tion products were well separated from the main peak, the LOQ (limits of quantitative) of the related substance 1, 2 and 3 respectively was 21 ng, 35 ng and 26 ng with good linearity within respective linear range(r≥0.999 0) , the average recovery was 99.7%, 100. 3% and 101. 2%, and RSD was 1. 1%, 0. 8% and 1. 7%, respectively(n=9). Conclusion:The method is specific and accu-rate, which can be used for the quality control of plerixafor.
