European Journal of Chemistry 2020, 11(2), 133-138 | doi: https://doi.org/10.5155/eurjchem.11.2.133-138.1972 | Get rights and content






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Inductively coupled plasma with mass-spectrometry method development and validation for gadolinium in gadolinium-based contrast agents of pharmaceutical formulations


Subramanya Srinivas Kona (1) orcid , Mallesh Changali (2) orcid , Mahesh Kalva (3) orcid , Narasimha Swamy Lakka (4,*) orcid

(1) Department of Analytical Research and Development, Jodas Expoim Private Limited, Hyderabad, 502279, India
(2) Department of Analytical Research and Development, Jodas Expoim Private Limited, Hyderabad, 502279, India
(3) Department of Analytical Research and Development, Jodas Expoim Private Limited, Hyderabad, 502279, India
(4) Department of Analytical Research and Development, Jodas Expoim Private Limited, Hyderabad, 502279, India
(*) Corresponding Author

Received: 16 Feb 2020 | Revised: 22 Mar 2020 | Accepted: 25 Mar 2020 | Published: 30 Jun 2020 | Issue Date: June 2020

Abstract


Gadolinium-based contrast agent interacts with the human body temporarily and improves the pictures of inside of the body produced by magnetic resonance imaging, computed tomography, X-rays and ultrasound and it also helps to distinguish the normal from abnormal conditions. In this study, the authors developed a simple, rapid, reliable and robust inductively coupled plasma mass-spectrometry method for estimation of gadolinium in gadolinium-based contrast agents to check the drug quality and ensure the patient safety. The samples were digested at 160°C using the microwave digestion system and the gadolinium was extracted in 0.4% (w/w) nitric acid. Interference of deposited gadolinium on sample cone and skimmer cone were investigated and evaluated. The developed method was validated as per ICH Q2 (R1) guideline and USP<730>. The precision was evaluated with six independent assays of gadolinium in each gadolinium-based contrast agent. The test method was found linear (r2 > 0.999) with five different levels covered from 25~200%, and accurate, mean recoveries were 92.5~107.5% at three different levels covered from 50~150%. The robustness was performed by changing the nitric acid concentration (0.4±0.04%, w/w) in diluent system. This method is suitable to quantitatively determine the amount of gadolinium in gadolinium-based contrast agent of drug products in presence of excipients used in formulation and also in drug substance.


Keywords


Gadolinium; Method validation; Method development; Microwave assisted digestion system; Gadolinium-based contrast agents (GBCAs); Inductively coupled plasma mass-spectrometry

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DOI: 10.5155/eurjchem.11.2.133-138.1972

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Jodas Expoim Private Limited, Hyderabad, 502279, India.

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How to cite


Kona, S.; Changali, M.; Kalva, M.; Lakka, N. Eur. J. Chem. 2020, 11(2), 133-138. doi:10.5155/eurjchem.11.2.133-138.1972
Kona, S.; Changali, M.; Kalva, M.; Lakka, N. Inductively coupled plasma with mass-spectrometry method development and validation for gadolinium in gadolinium-based contrast agents of pharmaceutical formulations. Eur. J. Chem. 2020, 11(2), 133-138. doi:10.5155/eurjchem.11.2.133-138.1972
Kona, S., Changali, M., Kalva, M., & Lakka, N. (2020). Inductively coupled plasma with mass-spectrometry method development and validation for gadolinium in gadolinium-based contrast agents of pharmaceutical formulations. European Journal of Chemistry, 11(2), 133-138. doi:10.5155/eurjchem.11.2.133-138.1972
Kona, Subramanya, Mallesh Changali, Mahesh Kalva, & Narasimha Swamy Lakka. "Inductively coupled plasma with mass-spectrometry method development and validation for gadolinium in gadolinium-based contrast agents of pharmaceutical formulations." European Journal of Chemistry [Online], 11.2 (2020): 133-138. Web. 11 Aug. 2020
Kona, Subramanya, Changali, Mallesh, Kalva, Mahesh, AND Lakka, Narasimha. "Inductively coupled plasma with mass-spectrometry method development and validation for gadolinium in gadolinium-based contrast agents of pharmaceutical formulations" European Journal of Chemistry [Online], Volume 11 Number 2 (30 June 2020)

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DOI Link: https://doi.org/10.5155/eurjchem.11.2.133-138.1972

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