PDF
Full
Outline
To establish an HPLC method for the determination of related substances in nifedipine.
HPLC was adopted on a PFP column (250 mm×4.6 mm, 5 μm) with a gradient elution system of 20 mmol·L-1 potassium dihydrogen phosphate solution and methanol, the flow rate was 1.0 mL·min-1, and the column temperature was maintained at 30 ℃. The detection wavelength was set at 265 nm.
The resolutions were good between the peaks of nifedipine and ten known impurities, including impurity D, 2-nitrobenzaldehyde, monoamide, hydroxy dehydro lactone, impurity C, dehydro-N-oxide, impurity A, impurity B, m-nifedipine, p-nifedi-pine. The resolutions between the known impurity peaks were not less than 1.5, the resolutions between the main peak of nifedipine and it’s front and back impurity peaks were not less than 2.0. The calibration curves of mass concentration of above known impurities were linear respectively in their concentration range of 0.000 2-0.015 mg·mL-1(r>0.999, n=7). The correlation coefficients of above known impurities were 1.000, 1.000, 1.000, 1.000, 0.999 9, 0.999 9, 0.999 9, 1.000, 0.999 9, 0.999 9, respectively. The average recovery rates of above known impurities were 93.1%(RSD=2.3%), 110.6%(RSD=1.9%), 109.2%(RSD=2.0%), 111.0%(RSD=2.1%), 108.1%(RSD=1.9%), 112.4%(RSD=1.8%), 110.8%(RSD=1.9%), 91.5%(RSD=3.1%), 98.9%(RSD=2.7%), 110.1%(RSD=2.6%), respectively. The detection limit of above known impurities was 0.000 06 mg·mL-1, the quantification limit of above known impurities was 0.000 2 mg·mL-1. The impurity determination results of the three batches of nifedipine samples showed that the content of the known impurities and the maximum single unknown impurity were less than 0.1%, the total impurities contents were less than 0.5%.
The method has good sensitivity and specificity, and it is suitable for the quality control of nifedipine.
PDF
128
57
| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
关闭全屏
No. 86 Xueyuan South Road, Haidian District, Beijing
010-62199257
qkjq@cast.org.cn
Copyright © 2025 China Association for Science and Technology. All rights reserved. For all open access content, the relevant licensing terms apply.
Sponsored by the Office of the Leading Group for Cybersecurity and Informatization of CAST, and supported by Science and Technology Review Publishing House
