Analysis of ICH-Q3D Endorsed Elemental Impurities in Macrolide Antibiotics by ICP-MS
1, 2, 3, 2, 1
- 1Department of Pharmacy, Vinayaka Mission’s College of Pharmacy, Vinayaka Mission’s Research Foundation (Deemed to be University), Salem, Tamil Nadu, INDIA.
- 2Department of Pharmaceutical Analysis, Vinayaka Mission’s College of Pharmacy, Vinayaka Mission’s Research Foundation (Deemed to be University), Salem, Tamil Nadu, INDIA.
- 3Department of Pharmaceutical Chemistry, Swamy Vivekanandha College of Pharmacy, Tiruchengode, Tamil Nadu, INDIA.
CORRESPONDENCE
Mr. Ravisankar Mathesan
Department of Pharmacy, Vinayaka Mission’s College of Pharmacy, Vinayaka Mission’s Research Foundation (Deemed to be University), Salem, Tamil Nadu, INDIA.
Received: 12-02-2023; Accepted: 14-08-2023.
Volume 57, Issue 4 · pp. 1219-1225 · 2023 · 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.
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Mathesan, R., Sekar, A., Raju, S. K., Mohan, K., & Sri, V. B. (2023). Analysis of ICH-Q3D Endorsed Elemental Impurities in Macrolide Antibiotics by ICP-MS. Indian Journal of Pharmaceutical Education and Research, 57(4), 1219-1225. https://doi.org/10.5530/ijper.57.4.145
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