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Physical Sciences › Chemistry › Analytical Chemistry
Management of validation of HPLC method for determination of acetylsalicylic acid impurities in a new pharmaceutical product
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Paper Summary
Conflicts of Interest
Identified Weaknesses
Rating Explanation
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Paper Summary
Paperzilla title
Aspirin-Glycine Tablets: Impurities Checked and Passed!
The study validated an HPLC method for determining impurities in acetylsalicylic acid-glycine tablets, confirming its linearity, accuracy, and precision within the tested range (0.005-0.40% salicylic acid). Forced degradation studies showed that the method can effectively separate the active ingredients and salicylic acid from degradation products.
Possible Conflicts of Interest
The authors acknowledge financial support from Medicofarma S.A., which could be a potential conflict of interest as they may have a vested interest in the successful validation of the method for their new pharmaceutical product.
Identified Weaknesses
Limited generalizability
The study is limited to a specific pharmaceutical product and its impurities, which may not be generalizable to other products or impurities.
Limited robustness testing
The robustness testing only evaluated a small change in temperature, and other potential variations in chromatographic conditions were not assessed.
Potential for improved methodology
The study uses a pharmacopoeial method, which may not be the most sensitive or specific method available.
Rating Explanation
This is a well-executed validation study that adheres to ICH guidelines and demonstrates the suitability of the HPLC method for its intended purpose. The identified limitations, while present, do not significantly detract from the overall quality of the study. However, the financial support from a pharmaceutical company warrants lowering the score due to a potential conflict of interest.
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File Information
Original Title:
Management of validation of HPLC method for determination of acetylsalicylic acid impurities in a new pharmaceutical product
File Name:
s41598-021-99269-x.pdf
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File Size:
0.97 MB
Uploaded:
July 14, 2025 at 10:49 AM
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