HPLC assay of epinephrine sulfonate in epinephrine injection
10.16438/j.0513-4870.2022-0408
- VernacularTitle:肾上腺素注射液中肾上腺素磺化物的HPLC检测方法研究
- Author:
Chu-chu ZHOU
1
;
Peng DU
1
;
Ya MENG
1
;
Zhi-hui LI
2
;
Li ZHANG
3
;
Xiu-ping GUO
1
;
Yu-jia ZHANG
1
;
Qiu-shi HAO
4
;
Wen-sheng ZHENG
1
Author Information
1. Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing City Key laboratory of Drug Delivery Technology and Novel Formulation, Beijing 100050, China
2. Guangxi Medical University, Nanning 530021, China
3. Anqing Medical College, Anqing 246052, China
4. Hebei Jinniuyuanda Pharmaceutical Technology Co., Ltd., Dingzhou 073000, China
- Publication Type:Research Article
- Keywords:
HPLC;
epinephrine injection;
epinephrine sulfonate;
assay;
quality standards
- From:
Acta Pharmaceutica Sinica
2022;57(9):2805-2810
- CountryChina
- Language:Chinese
-
Abstract:
An HPLC method was established for the assay of epinephrine sulfonate (impurity F) in epinephrine injection. The determination was performed on an AQUASIL C18 (100 mm × 4.6 mm, 3 μm) column with a gradient elution system, and the mobile phase was consisted of monopotassium phosphate solution (mobile phase A) and acetonitrile (mobile phase B). The injection volume was 40 μL. The detection wavelength was at 210 nm and the column temperature was 25 ℃. The total analytical time was 40 min. The results showed that the standard cure of epinephrine sulfonate (impurity F) between peak area and concentration exhibited good linear relationship within the ranges of 0.520-12.480 μg·mL-1 and the R2 = 0.999 8. The average recovery rate was 103.04% and the RSD was 2.00%. The limit concentration of detection was 0.104 μg·mL-1 and the limit concentration of quantitation was 0.520 μg·mL-1. The method could be applied to the determination of epinephrine sulfonate in epinephrine injection with high accuracy and precision, as well as good sensitivity. It could also enhance the quality standards of epinephrine-related products.
