LABORATORY INVESTIGATION DURING THE CONTROL OF THE PHARMACEUTICAL DRUGS ON THE INDICATOR "RELATED SUBSTANCES" BY THE METHOD OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY
Аннотация и ключевые слова
Аннотация (русский):
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.

Ключевые слова:
statins, hypolipidemic effect, high-performance liquid chromatography, related substances, laboratory investigation
Список литературы

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).

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