Determination of related substances in esmolol hydrochloride injection by HPLC method
10.12206/j.issn.2097-2024.202509049
- VernacularTitle:HPLC法在盐酸艾司洛尔注射液中有关物质含量测定的应用
- Author:
Jun YE
1
;
Chenyu ZHANG
2
;
Haifeng ZHOU
3
Author Information
1. Shanghai Jing’an Institute for Food and Drug Control, Shanghai 200435, China.
2. Department of Emergency, Huashan Hospital, Fudan University, Shanghai 200040, China.
3. Department of Pharmacy, Huadong Hospital, Fudan University, Shanghai 200040, China.
- Publication Type:Originalarticles
- Keywords:
esmolol hydrochloride injection;
HPLC;
related substances;
quality assessment;
gradient elution
- From:
Journal of Pharmaceutical Practice and Service
2026;44(9):477-482
- CountryChina
- Language:Chinese
-
Abstract:
Objective To determine the related substances in esmolol hydrochloride injection by HPLC method. Methods A Waters XBridge TM C18 （4.6 mm×150 mm,5 µm） column packed with octadecylsilane-bonded silica gel was used, with phosphate buffer （3.0 g of potassium dihydrogen phosphate was taken, dissolved in water and diluted to 650 ml）-acetonitrile-methanol （65∶15∶20） as the mobile phase A, and mobile phase A mixed with methanol （65∶35） as the mobile phase B. The related substances in the test sample and those generated after forced degradation were qualitatively and quantitatively analyzed by the impurity reference standard method, with an injection volume of 20 μl, a column temperature of 30℃, a flow rate of 1.0 ml/min and a detection wavelength of 222 nm. Results The separation between esmolol hydrochloride and neighboring impurities as well as between each impurity was greater than 1.5; the impurities showed good linearity in their respective linear ranges （r>0.999）. The average recovery of impurity a （Imp-a） was 99.1% with an RSD of 0.56%; the average recovery of impurity b（Imp-b）was 96.0% with an RSD of 0.98%; the average recovery of impurity c （Imp-c） was 100.7% with an RSD of 1.24%; the average recovery of impurity d （Imp-d） was 99.0% with an RSD of 0.12%; the average recovery of impurity e （Imp-e） was 100.7% with an RSD of 0.64%; and the impurity f （Imp-f） average recovery was 101.7% with an RSD of 3.26%; impurity g （Imp-g） average recovery was 99.1% with an RSD of 1.45%. Conclusion This method could evaluate the quality of esmolol hydrochloride injection more accurately than the current standard and could provide data reference for the quality evaluation system.
