HPLC-RID method for the determination of glucosamine hydrochloride in amitriptyline enteric-coated tablets
10.19778/j.chp.2024.01.010
- VernacularTitle:HPLC-RID法测定氨糖美辛肠溶片中盐酸氨基葡萄糖含量
- Author:
YUAN Jinye
;
CHEN Qi
;
XUE Qiaoru
;
CHEN Hua
- Publication Type:Journal Article
- Keywords:
HPLC;
RID;
enteric-coated tablets of aspartame;
glucosamine hydrochloride;
content determination
- From:
Drug Standards of China
2024;25(1):062-067
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To establish a method for the determination of glucosamine hydrochloride content in aminoglycine enteric coated tablets by high-performance liquid chromatography with differential refractive detector.
Methods: Waters XBridge Amide (4.6 mm×250 mm, 3.5 μm) column was used. The mobile phase was 80% acetonitrile solution (1 000 mL containing 1 mL ammonia) at the flow rate of 1.2 mL·min-1. Column temperature was set on 40 ℃; Injecting volume was 20 μL with differential refraction detector (RID) detection.
Results: The detection limit of glucosamine hydrochloride was 0.03 mg·mL-1, and the limit of quantification was 0.125 mg·mL-1. It showed a good linear relationship in the mass concentration range of 0.72-7.56 mg·mL-1. The average recovery was 99.4% (RSD=0.85%,n=9). The content of glucosamine hydrochloride in 7 batches of aminosamine enteric-coated tablets was measured in the range of 93%-107%.
Conclusion: The proposed method is fast, accurate, specific and durable, and can be used for the determination of glucosamine hydrochloride, which provides a reference for effectively controlling the quality of aminoxymetacin enteric-coated tablets.
- Full text:20240810132236085120240210.pdf