Improvement of the content determination method for isosorbide dinitrate tablets
10.19778/j.chp.2025.05.017
- VernacularTitle:硝酸异山梨酯片含量测定方法的改进
- Author:
Yanxia ZHANG
1
;
Feng HAN
1
;
Yujian QIAN
1
;
Xiaofei YUN
1
;
Ying SUN
1
Author Information
1. 北京市朝阳区食品药品安全监控中心,北京 100124
- Publication Type:Journal Article
- Keywords:
isosorbide dinitrate tablets;
content determination;
content uniformity;
high-performance liquid chro-matography
- From:
Drug Standards of China
2025;26(5):556-560
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the reasons for the low results obtained by the determination of isosorbide dini-trate tablets content using the methods in the Chinese Pharmacopoeia and to improve the content determination method.Methods:The content of isosorbide dinitrate in 10 tablets was determined by high-performance liquid chromatography(HPLC)using a Phenomenex Luna C18 column(4.6 mm ×250 mm,5 μm)for separation,with a mobile phase of methanol-water(54∶46),a flow rate of 1.0 mL·min-1,and a UV detector set at a wavelength of 230 nm.The average content of 10 tablets was taken as the result of the content determination.Results:Isosor-bide dinitrate showed good linearity in the range of 49.22 to 1 230.5 μg·mL-1(r=0.999 96);the relative stand-ard deviation was 0.11％,the recovery rate was 96.0％,and the RSD was 1.5％(n=9).Conclusion:This method simplifies the experimental operations and steps,can eliminate the interference factors introduced by the original method,and improves the accuracy of the detection results.
