UDC 615.011.3 UDC 543.544.5.068.7

LABORATORY INVESTIGATION DURING THE CONTROL OF THE PHARMACEUTICAL DRUGS ON THE INDICATOR "RELATED SUBSTANCES" BY THE METHOD OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY Laboratory investigation during the control of the pharmaceutical drugs on the indicator "Related substances" by the method of high-performance liquid chromatography

Published in From Chemistry Towards Technology Step-By-Step · Volume 4, Issue 2 · Pages 72–76 · Rubric: Scientific articles
DOI: https://doi.org/10.52957/2782-1900-2024-4-2-72-76
Received: 24.05.2023 Accepted: 16.06.2023 Published: 23.06.2023 Language of publication: ENG
We provided the laboratory investigation during the control of the pharmaceutical drugs on the indicator "Related substances" by the method of high-performance liquid chromatography (HPLC). It allows us to study the related substances of the pharmaceutical drugs. Also we considered three hypotheses which could affect the final result. Consequently, the sample preparation procedure was found to be an error made by the laboratory personnel.
statins, hypolipidemic effect, high-performance liquid chromatography, related substances, laboratory investigation
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1. European Medicines Agency (2006) ICH Topic Q 3 B(R2) Impurities is new drug products [online]. Available at: http://www.emea.eu.int

2. Emshanova, S.V., Potanina, O.G., Budanova, E.V. & Chistyakov, V.V. (2018) Russia State Pharmacopoeia. XIV ed. M.: OOO "GARANT" (in Russian).

3. Rudakov, O.B., Vostorov, I.A., Fedorov, S.V., Filippov, A.A., Selemenev, V.F. & Pridantsev A.A. (2004) The chromatographer's companion. Voronezh: Vodoley (in Russian).

4. Illarionova, E.A. & Syrovatsky, I.P. (2018) High-performance liquid chromatography. Theoretical foundations of the method. Irkutsk: IGMU (in Russian).

5. Polyakova, O.A. & Ostroumova, O.D. (2022) The problem of choice: original pharmaceutical or generic? Emphasis on rosuvastatin, Racional'naya Farmakoterapiya v Kardiologii, 18(2) pp. 225-230. DOIhttps://doi.org/10.20996/1819-6446-2022-04-10 [online]. Available at: https://doi.org/10.20996/1819-6446-2022-04-10 (accessed 12.04.2023) (in Russian).

6. Bajaj, T. & Giwa, A.O. (2021) Rosuvastatin, Stat Pearls. Treasure Island (FL): StatPearls Publishing LLC.

7. Epstein, N.A. & Emshanova, S.V. (2018) On the requirements for the suitability of a chromatographic system for quality control of medicinal substances and preparations by HPLC, Himiko-farmacevticheskij zhurnal, (11), pp. 34-40 (in Russian).