Development of a stability-indicating method for evaluation of impurity profile of Atorvastatin film-coated tablets using cyano column based on core-shell technology

Authors

  • Elena Trajchova Kovachovska Institute of Research and Development, Alkaloid AD Skopje, Republic of N. Macedonia
  • Jelena Acevska Faculty of Pharmacy, University “Ss Cyril and Methodius”, Republic of N. Macedonia
  • Katerina Brezovska Faculty of Pharmacy, University “Ss Cyril and Methodius”, Republic of N. Macedonia
  • Stefan Trajkovic Institute of Research and Development, Alkaloid AD Skopje, Republic of N. Macedonia
  • Ivana Mitrevska Institute of Research and Development, Alkaloid AD Skopje, Republic of N. Macedonia
  • Sonja Ugarkovic Institute of Research and Development, Alkaloid AD Skopje, Republic of N. Macedonia
  • Aneta Dimitrovska Faculty of Pharmacy, University “Ss Cyril and Methodius”, Republic of N. Macedonia

DOI:

https://doi.org/10.20450/mjcce.2022.2478

Keywords:

forced degradation study, atorvastatin, stability-indicating method, cyano fused-core shell column

Abstract

This research highlights the specificity of the new stability-indicating method developed to evaluate the impurity profile of Atorvastatin film-coated tablets. The proposed method has the ability to capture any possible changes that may occur during the stability studies over time and under different stress factors, and is selective enough to enable quality control of finished product from different suppliers of active pharmaceutical ingredient (API)/excipients. 

Satisfactory critical peak resolution between specified and unspecified impurities was achieved using the fused-core shell technology and extensively endcapped diisopropyl-cyanopropylsilane stationary phase (Halo ES-CN 150 mm × 4.6 mm, 2.7 µm), with a 10 mM ammonium formate buffer pH 3.5 and acetonitrile as mobile phase. A potential worse case impurity profile was assumed by using retained samples combined with the data obtained for samples manufactured with APIs from different suppliers exposed to the forced degradation study. The mass balance for stressed samples demonstrated the stability-indicating capability of the proposed method.

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Published

2022-06-23 — Updated on 2022-06-23

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How to Cite

Trajchova Kovachovska, E., Acevska, J., Brezovska, K., Trajkovic, S., Mitrevska, I., Ugarkovic, S., & Dimitrovska, A. (2022). Development of a stability-indicating method for evaluation of impurity profile of Atorvastatin film-coated tablets using cyano column based on core-shell technology. Macedonian Journal of Chemistry and Chemical Engineering, 41(1). https://doi.org/10.20450/mjcce.2022.2478

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Section

Analytical Chemistry

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