Objective: To establish an HPLC method to determine the assay of paracetamol suppositories and carry out the related exploratory research based on the problems found in the national evaluation sampling inspection. Methods: Agilent C18 plus (250 mm×4.6 mm, 5 μm) column was used to determine the assay of paracetamol suppository. The mobile phase was 0.05 mol·L-1 ammonium acetate -methanol (85∶15), the flow rate was 1 mL·min-1, and the detection wavelength was 257 nm. Results: The linear range of paracetamol was 1.5-300 μg·mL-1 (r=1.000), and the average recovery was 100.1%, precision was 0.44%. A new method for the determination of paracetamol suppositories content was established, which solved the problems of sample preparation and precision of the original method. Meanwhile, the content uniformity was added in the quality standard, which assures the uniformity of product content. Conclusion: The method has strong specificity, high accuracy, good reproducibility and good durability. The problem of poor precision and accuracy in the determination of paracetamol content was well solved and provides an accurate and practical method for the quality control of the suppository.
DOU Yan-li, ZHANG Nai-bin, CHEN Zhen, LI Lin, YANG Shu-juan, WANG Xue, ZHANG Lei
. Quality related problems and solutions of paracetamol suppositories in national drug sampling and inspection[J]. Chinese Journal of Pharmaceutical Analysis, 2022
, 42(3)
: 531
-536
.
DOI: 10.16155/j.0254-1793.2022.03.22
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