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Indian Journal of Pharmaceutical Education and ResearchNOW IN
Article

Development of an Ion Chromatography Method for the Determination of Organic Impurities in Ferumoxytol

Naga Sankara Rao Deepala1★, Sasikanth Pedapalli1★, Kantamsetti Jagadeesh2★, Mohammad Shahidul Islam3★, Prakash Gadipelli4★, Kholood A. Dahlous4★, Mahboob Alam5★, Rudraraju Ramesh Raju1★★ Corresponding author

  1. 1Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Andhra Pradesh, INDIA.
  2. 2Department of Physics, Sri Vasavi Engineering College, Pedatadepalli, Tadepalligudem, Andhra Pradesh, INDIA.
  3. 3Department of Chemistry, College of Science, King Saud University, Riyadh, SAUDI ARABIA.
  4. 4Department of Chemistry, Aditya University, Surampalem, Andhra Pradesh, INDIA.
  5. 5Division of Chemistry and Biotechnology, Dongguk University, Dongdaero, Gyeongjusi, Gyeongjusi, SOUTH KOREA.

CORRESPONDENCE

Naga Sankara Rao Deepala

Prof. Rudraraju Ramesh RajuDepartment of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar-522510, Andhra Pradesh, INDIA.

rrraju1@gmail.com

Received: 16-11-2024; Revised: 24-01-2025; Accepted: 02-04-2025.

Volume 59, Issue 3S · pp. s1110–s1116 · PUBLISHED Jul-Sep 2025 · DOI: 10.5530/ijper.20251319

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ABSTRACT

Aim: To the development of an ion chromatography method for the determination of organic impurities in Ferumoxytol. Materials and Methods: A new ion chromatographic method was employed for the precise and suitable quantification of organic impurities in Ferumoxytol drug. Specifically, LOD, LOQ, Linearity, and Accuracy evaluations were conducted to thoroughly validate each of these areas. Results: All the studied carbohydrate impurities showed linear ranges within 0.0005 to 0.0030 mg/mL with the correlation coefficients higher than 0.9991. The limits of detection were all less than 0.0002 mg/mL. The limits of quantification were all less than 0.0006 mg/mL. The RSDs of the method were less than 3%. Conclusion: This method showed a lot of promise for precise impurity testing in Ferumoxytol drug substance, improving pharmaceutical quality assurance and making sure that patients are protected.

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    Deepala, N. S. R., Pedapalli, S., Jagadeesh, K., Islam, M. S., Gadipelli, P., Dahlous, K. A., Alam, M., & Raju, R. R. (2025). Development of an Ion Chromatography Method for the Determination of Organic Impurities in Ferumoxytol. Indian Journal of Pharmaceutical Education and Research, 59(3S), s1110–s1116. https://doi.org/10.5530/ijper.20251319