Management of validation of HPLC method for determination of acetylsalicylic acid impurities in a new pharmaceutical product
Kazimierz Pułaski University of Technology and Humanities in Radom · Krakow University of Economics
Abstract
Abstract The work mainly focused on a validation of the method for determining the content of salicylic acid and individual unknown impurities in new pharmaceutical product—tablets containing: 75, 100 or 150 mg of acetylsalicylic acid and glycine in the amount of 40 mg for each dosage. The separation of the components was carried out by means of HPLC, using a Waters Symmetry C18 column (4.6 × 250 mm, 5 μm) as the stationary phase. The mobile phase consisted of a mixture of 85% orthophosphoric acid, acetonitrile and purified water (2:400:600 V/V/V). Detection was carried out at a wavelength of 237 nm, with a constant flow rate of 1.0 ml min −1 . In order to verify the method, linearity, precision (repeatability…
Citation impact
- FWCI
- 210.20
- Percentile
- 100%
- References
- 15
Authors
6- MKMałgorzata KowalskaCorresponding
Kazimierz Pułaski University of Technology and Humanities in Radom
- MWMagdalena Woźniak
Kazimierz Pułaski University of Technology and Humanities in Radom
- MKMichał Kijek
- PMPaulina Mitrosz
Kazimierz Pułaski University of Technology and Humanities in Radom
- JSJerzy Szakiel
Krakow University of Economics
Topics & keywords
- Repeatability
- Chromatography
- Salicylic acid
- Reproducibility
- High-performance liquid chromatography
- Impurity
- Detection limit
- Acetonitrile