Management of validation of HPLC method for determination of acetylsalicylic acid impurities in a new pharmaceutical product

🤖 Plain-English Summary

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 method was validated successfully.

🔑 Key Findings

• 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 .

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