Determination of EDTA-2 Na in Amphotericin B by HPLC
- VernacularTitle:HPLC法测定两性霉素B中乙二胺四乙酸二钠含量
- Author:
Cheng WANG
;
Ting LUO
;
Ling LIN
- Publication Type:Journal Article
- Keywords:
Amphotericin B;
EDTA-2Na;
Assay;
HPLC
- From:
China Pharmacist
2016;19(2):379-381
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish an HPLC method for the determination of EDTA-2Na in amphotericin B. Methods: A Waters C18 column(50 mm × 4. 6mm, 5 μm) was used. The mobile phase A was acetic acid solution (1. 5 ml acetic acid was added into 1000ml water, and 41 ml 10% tetrabutylammonium hydroxide solution was added), and the mobile B was acetonitrile with gradient e-lution. The flow rate was 0. 8 ml·min-1 , the column temperature was 30℃, the detection wavelength was 260 nm and the injection volume was 25μl. Results:The results showed that EDTA-2Na in amphotericin B could be detected without any interference. The cal-ibration curve of EDTA-2Na was linear within the range of 0. 92-7. 37μg·ml-1(r=0. 999 9), the LOD was 1. 93 ng·ml-1 and the LOQ was 6. 45 ng·ml-1. The average recovery was 102. 5% (RSD=2. 8%, n=9). Conclusion: The method is simple, selective and accurate. It can be used for the quality control of EDTA-2Na in amphotericin B.
