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

Indian Journal of Pharmaceutical Education and Research

  • Naga Sankara Rao Deepala1Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Andhra Pradesh, INDIA.
  • Sasikanth Pedapalli1Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Andhra Pradesh, INDIA.
  • Kantamsetti Jagadeesh2Department of Physics, Sri Vasavi Engineering College, Pedatadepalli, Tadepalligudem, Andhra Pradesh, INDIA .
  • Mohammad Shahidul Islam3Department of Chemistry, College of Science, King Saud University, Riyadh, SAUDI ARABIA.
  • Prakash Gadipelli4Department of Chemistry, Aditya University, Surampalem, Andhra Pradesh, INDIA .
  • Kholood A. Dahlous4Department of Chemistry, Aditya University, Surampalem, Andhra Pradesh, INDIA .
  • Mahboob Alam5Division of Chemistry and Biotechnology, Dongguk University, Dongdaero, Gyeongjusi, Gyeongjusi, SOUTH KOREA.
  • Rudraraju Ramesh Raju1Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Andhra Pradesh, INDIA.

Volume 59 Issue 3s Pages s1110-s1116

DOI: 10.5530/ijper.20251319

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.

Keywords

  • Ferumoxytol
  • Ion Chromatography
  • Method Development
  • Organic Impurities
  • Pharmaceutical Analysis
IJOPP

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