The DOI matches its Crossref record; 9 of the 9 references it cites were found in a registry or an index.
Management of validation of HPLC method for determination of acetylsalicylic acid impurities in a new pharmaceutical product
Open accessAbstract
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 and reproducibility), accuracy, specificity, range, robustness, system precision, stability of the test and standard solution, limit of quantification and forced degradation were determined. Validation tests were performed in accordance with ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) guidelines. The method was validated successfully. It was confirmed that the method in a tested range of 0.005–0.40% salicylic acid with respect to acetylsalicylic acid content is linear, precise and accurate.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
Arzneimittelforschung: Erstanwendung am Menschen in der Phase I
Miletzki, B., & Gleiter, C. H. (2005) · Bundesgesundheitsblatt Gesundheitsforsch.Gesundheitsschutz · doi:10.1007/s00103-005-1024-7 · Cited by 9,355
Development of forced degradation and stability indicating studies of drugs—A review
Blessy, M., Patel, R. D., Prajapati, P. N., & Agrawal, Y. K. (2014) · Journal of Pharmaceutical Analysis · doi:10.1016/j.jpha.2013.09.003 · Cited by 1,032
Guidelines from the International Conference on Harmonisation (ICH)
Branch, S. K. (2005) · Journal of Pharmaceutical and Biomedical Analysis · doi:10.1016/j.jpba.2005.02.037 · Cited by 333
Method validation strategies involved in non-targeted metabolomics
Naz, S., Vallejo, M., García, A., & Barbas, C. (2014) · Journal of Chromatography A · doi:10.1016/j.chroma.2014.04.071 · Cited by 332
Comparison of various international guidelines for analytical method validation
Chandran, S., & Singh, R. S. P. (2007) · Die Pharmazie · doi:10.31083/ph.2007.1.5064 · Cited by 159
Zakeri‐Milani, P., Barzegar-Jalali, M., Tajerzadeh, H., Azarmi, Y., & Valizadeh, H. (2005) · Journal of Pharmaceutical and Biomedical Analysis · doi:10.1016/j.jpba.2005.04.008 · Cited by 107
Structural characteristics of prostaglandin synthetase from sheep vesicular gland.
Roth, G. J., Siok, C. J., & Ozols, J. (1980) · Journal of Biological Chemistry · doi:10.1016/s0021-9258(19)86029-5 · Cited by 102
Synthesis of aspirin-ligated cisplatin derivatives and its slow release study over MIL-101(Fe)
Rosari, V. A., Lestari, W. W., & Firdaus, M. (2020) · Chemical Papers · doi:10.1007/s11696-020-01114-4 · Cited by 7
Non-steroidal anti-inflammatory drugs: is the balance shifting?
Somerville, K. W., & Noble, G. (1997) · Age and Ageing · doi:10.1093/ageing/26.6.417 · Cited by 3
Research works printed but not linked: 10
- Funk, W. et al. Quality Assurance in Analytical Chemistry: Applications in Environmental, Food, and Materials Analysis, Biotechnology, and Medical Engineering (Wiley, 2006). · doi:10.1002/9783527609444
- Górecka, S. Walidacja procesów wytwarzania produktów leczniczych w ramach systemu zapewnienia jakości. Probl. Jakości. 37, 17–22 (2005).
- Akay, C. et al. Rapid and simultaneous determination of acetylsalicylic acid, paracetamol, and their degradation and toxic impurity products by HPLC in pharmaceutical dosage forms. Turk. J. Med. Sci. 38, 167–173 (2008).
- Tangri, P. & Rawat, P. S. Validation: A critical parameter for quality control of pharmaceuticals. J. Drug Deliv. Ther. 2, 34–40 (2012).
- Busse, W. The significance of quality for efficacy and safety of herbal medicinal products. Ther. Innov. Regul. Sci. 34, 15–23 (2000).
- Bowie, D. & McKinney, R. A. Neurophysiology of inhibitory and excitatory amino acid receptors. J. Physiol. 588, 29–32 (2010). · doi:10.1113/jphysiol.2009.185561
- Kusche, W., Paxinos, R., Haselmann, J., Schwantes, U. & Breddin, H. K. Acetylsalicylic acid tablets with glycine improve long-term tolerability in antiplatelet drug therapy. Adv. Therapy 20, 237–245 (2003). · doi:10.1007/bf02849852
- Müller, P., Dammann, H. G., Bergdolt, H. & Simon, B. The effect of glycine on the gastroduodenal tolerability of acetylsalicylic acid. An endoscopic, controlled double-blind study in healthy subjects. Arzneimittelforschung 41, 812–814 (1991).
- Kamalakkannan, V., Puratchikody, A., Ramanathan, L. & Jayapraba, S. Development and validation of a dissolution test with reversed-phase high performance liquid chromatographic analysis for Candesartan cilexetil in tablet dosage forms. Arab. J. Chem. 9, S867–S873 (2016). · doi:10.1016/j.arabjc.2011.09.011
- Yenduri, G. & Navuluri, S. Analytical high performance liquid chromatography method for estimating the combination of aspirin and omeprazole in bulk and tablet dosage form. Marmara Pharmaceut. J. 22, 502–510 (2018).
Cited by
Unveiling the mechanisms and challenges of cancer drug resistance
Khan, S. U., Fatima, K., Aisha, S., & Malik, F. (2024) · Cell Communication and Signaling · doi:10.1186/s12964-023-01302-1 · Cited by 417
Data Augmentation techniques in time series domain: a survey and taxonomy
Iglesias, G., Talavera, E., González-Prieto, Á., Mozo, A., & Gómez-Canaval, S. (2023) · Neural Computing and Applications · doi:10.1007/s00521-023-08459-3 · Cited by 347
Artificial intelligence in dentistry-a review
Ding, H., Wu, J., Zhao, W., Matinlinna, J. P., Burrow, M. F., & Tsoi, J. K. H. (2023) · Frontiers in Dental Medicine · doi:10.3389/fdmed.2023.1085251 · Cited by 297
Machine learning with a reject option: A survey
Hendrickx, K., Perini, L., Van der Plas, D., Meert, W., & Davis, J. (2024) · Machine Learning · doi:10.1007/s10994-024-06534-x · Cited by 134
Colelli, F. P., Wing, I. S., & Cian, E. D. (2023) · Scientific Reports · doi:10.1038/s41598-023-31469-z · Cited by 114
Metadata
- Authors
- Kowalska, M., Woźniak, M., Kijek, M., Mitrosz, P., Szakiel, J., & Turek, P.
- Venue
- Scientific Reports
- Published
- 2022-01-06
- Volume
- 12
- Issue
- 1
- Pages
- 1-1
- ISSN
- 2045-2322 (ISSN-L)
- OpenAlex
- W4205765055
- Cited by
- 2,117
- References
- 9
- FWCI
- 221.07
- Type
- journal article
- Language
- en
- Open access
- gold
- Licence
- creativecommons.org/licenses/by/4.0 (tdm)
- creativecommons.org/licenses/by/4.0 (vor)
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
How to cite
Cite CoChat for the checks on this page, and the paper for its own findings.
- This page
- CoChat. (2026). Citation check: Management of validation of HPLC method for determination of acetylsalicylic acid impurities in a new pharmaceutical product. https://app.cochat.ai/papers/10.1038/s41598-021-99269-x
- The paper
- Kowalska, M., Woźniak, M., Kijek, M., Mitrosz, P., Szakiel, J., & Turek, P. (2022). Management of validation of HPLC method for determination of acetylsalicylic acid impurities in a new pharmaceutical product. Scientific Reports. https://doi.org/10.1038/s41598-021-99269-x
Data sources
Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
