Analysis of ICH-Q3D Endorsed Elemental Impurities in Macrolide Antibiotics by ICP-MS

Indian Journal of Pharmaceutical Education and Research

  • Ravisankar Mathesan1Department of Pharmacy, Vinayaka Mission’s College of Pharmacy, Vinayaka Mission’s Research Foundation (Deemed to be University), Salem, Tamil Nadu, INDIA.
  • Alexandar Sekar2Department of Pharmaceutical Analysis, Vinayaka Mission’s College of Pharmacy, Vinayaka Mission’s Research Foundation (Deemed to be University), Salem, Tamil Nadu, INDIA.
  • Senthil Kumar Raju3Department of Pharmaceutical Chemistry, Swamy Vivekanandha College of Pharmacy, Tiruchengode, Tamil Nadu, INDIA.
  • Kumar Mohan2Department of Pharmaceutical Analysis, Vinayaka Mission’s College of Pharmacy, Vinayaka Mission’s Research Foundation (Deemed to be University), Salem, Tamil Nadu, INDIA.
  • Venkateswarlu Bendi Sri1Department of Pharmacy, Vinayaka Mission’s College of Pharmacy, Vinayaka Mission’s Research Foundation (Deemed to be University), Salem, Tamil Nadu, INDIA.

Volume 57 Issue 4 Pages 1219-1225

DOI: 10.5530/ijper.57.4.145

Abstract

Aim: The objective of this study was to determine the amount of twenty-three elemental impurities in Azithromycin API. A rapid, selective, precise, accurate and sensitive approach for detecting elemental impurities in Azithromycin API was developed and validated using Inductively Coupled Plasma-Mass Spectrometry (ICP-MS). Background: Conventional analytical methods used in pharmacopoeia’s are less sensitive and accurate to detect heavy metal impurities. Concerning this issue, a new inductively coupled plasma mass spectrometry-based method was developed and validated as a different choice to investigate the Elemental impurities in an Azithromycin API sample. Materials and Methods: In the present research work, test samples were prepared with microwave supported acid digestion. Results: After a sequence of trails, the mixture of nitric acid, hydrochloric acid, and hydrogen peroxide (4 mL: 1 mL: 0.5 mL) with the accepted recovery range was chosen for the Azithromycin API's digestion. Conclusion: According to ICH and USP 233 guidelines, the proposed technique was successfully validated using ICP-MS for linearity, precision, accuracy, LOD, LOQ, and ruggedness.

Keywords

  • Azithromycin API
  • Elemental Impurities
  • Inductively coupled plasma mass spectrometry
  • Method Development
  • ICH Guidelines
IJOPP

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