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Article

Development of a Novel, Fast, Simple HPLC Method for Determination of Atorvastatin and its Impurities in Tablets

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Department of Pharmaceutical Chemistry, I. Horbachevsky Ternopil National Medical University, Maidan Voli 1, 46001 Ternopil, Ukraine
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Municipal Institution of Higher Education, Volyn Medical Institute of The Volyn Oblast Counsil, 43025 Lutsk, Ukraine
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Replek Farm Ltd., St. Kozle 188, 1000 Skopje, North Macedonia
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Department of Organic and Bioorganic Chemistry, Zaporizhzhya State Medical University, Maiakovskyi Avenue 26, 69035 Zaporizhzhya, Ukraine
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Department of Pharmacology, Medical Faculty, St. Cyril and Methodius University, 1000 Skopje, North Macedonia
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Department of Medicinal Chemistry, Faculty of Pharmacy, Mansoura University, El-Gomhoureya Street, 35516 Mansoura, Egypt
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Department of General, Bioinorganic, Physical and Colloidal Chemistry, Danylo Halytsky Lviv National Medical University, St. Pekarska 69, 79010 Lviv, Ukraine
*
Author to whom correspondence should be addressed.
Academic Editor: Roman B. Lesyk
Received: 16 March 2021 / Revised: 1 April 2021 / Accepted: 1 April 2021 / Published: 5 April 2021
Our main target and concept was to develop a method for the determination of the most prescribed antilipemic drug, atorvastatin, together with its related substances, with a single sample preparation and during a single chromatographic run, in the shortest possible period of time, with the lowest possible mobile phase consumption. A new rapid, simple chromatographic method for the determination of atorvastatin and its main specified impurities was developed, using different chromatographic columns. With this new concept of a mobile phase and a powerful core–shell, or a superficially porous silica-based column, satisfactory results for targeted parameters, such as critical peak resolution, run time length, and column backpressure, were achieved. The analysis is performed within a run duration of less than 15 min, which is about six times shorter than the official European Pharmacopoeia method. The chromatogram performances suggests that the method limit of quantification (LOQ) can be about 7 times lower, and the limit of detection (LOD) about 20 times lower, using an injection volume of only 2 µl. This was confirmed by the performed method validation in accordance with the International Conference on Harmonization (ICH) guideline for the validation of analytical procedures Q2(R1), where the selectivity, linearity, accuracy, precision, limit of quantification, and limit of detection were tested and confirmed. View Full-Text
Keywords: atorvastatin; impurities; liquid chromatography; method optimization; tablets atorvastatin; impurities; liquid chromatography; method optimization; tablets
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MDPI and ACS Style

Shulyak, N.; Piponski, M.; Kovalenko, S.; Bakovska Stoimenova, T.; Balkanov, T.; El-Subbagh, H.I.; Drapak, I.; Omotosho, J.O.; Logoyda, L. Development of a Novel, Fast, Simple HPLC Method for Determination of Atorvastatin and its Impurities in Tablets. Sci. Pharm. 2021, 89, 16. https://0-doi-org.brum.beds.ac.uk/10.3390/scipharm89020016

AMA Style

Shulyak N, Piponski M, Kovalenko S, Bakovska Stoimenova T, Balkanov T, El-Subbagh HI, Drapak I, Omotosho JO, Logoyda L. Development of a Novel, Fast, Simple HPLC Method for Determination of Atorvastatin and its Impurities in Tablets. Scientia Pharmaceutica. 2021; 89(2):16. https://0-doi-org.brum.beds.ac.uk/10.3390/scipharm89020016

Chicago/Turabian Style

Shulyak, Nataliia; Piponski, Marjan; Kovalenko, Sergiy; Bakovska Stoimenova, Tanja; Balkanov, Trajan; El-Subbagh, Hussein I.; Drapak, Iryna; Omotosho, Joy O.; Logoyda, Liliya. 2021. "Development of a Novel, Fast, Simple HPLC Method for Determination of Atorvastatin and its Impurities in Tablets" Sci. Pharm. 89, no. 2: 16. https://0-doi-org.brum.beds.ac.uk/10.3390/scipharm89020016

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