METHODS AND OBJECTS OF CHEMICAL ANALYSIS ISSN title: "Metody i obʺekty himičeskogo analiza" An international journal devoted to all aspects of Analytical chemistry ISSN 2413-6166 (Online), ISSN 1991-0290 (Print)
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VALIDATION OF ASSAY FOR SENECIPHYLINE AND RELATED IMPURITIES IN PLATYPHYLLINE HYDROTARTRATE SUBSTANCE AND «PLATYPHYLLINE- ZDOROVIE» INJECTABLE PREPARATION BY USING RP HPTLC METHOD

O.V. KOLISNYK, O.A. ZINCHENKO, V.P. GEORGIYEVSKIY

References:

1. Derzhavna farmakopeya Ukrayiny. Derzhavne pidpryyemstvo "Naukovo-ekspertnyy farmakopeynyy tsentr". 1st edn. Kharkiv: RIREH, 2001. P. 556. Supplement 1. 2004. P. 520. Supplement 2. 2008. P. 620.

2. European Pharmacopoeia 8th edn. Council of Europe: France, Strasbourg, 2013. P. 3655.

3. Analiticheskaya khimiya v sozdanii, standartizacii i kontrole kachestva lekarstvennykh sredstv. Kharkiv: НТМТ: in 3 Volumes in Russian. Ed. Corresponding Member of NAS of Ukraine V.P. Georgievskiy. Kharkiv: НТМТ, 2011, V. 1. P. 464. V. 2. P. 474. V. 3. P. 520.

4. Technical Guide for the Elaboration of Monographs. European Pharmacopoeia. European Directorate for the Quality of Medicines & HealthCare. 7th Edition. Council of Europe: France, Strasbourg, 2015. P. 67.

5. Validation of Analytical procedures: Text and Methodology Q2 (R1). In: www.ich.org

6. Renger B., Vйgh Z., Ferenczi-Fodor K. Validation of thin layer and high performance thin layer chromatographic methods. J.Chromatogr.A., 2011, 1218(19), 2712–2721.

7. Ferenczi-Fodor K., Vйgh Z., Renger B. Impurity profiling of pharmaceuticals by thin-layer chromatography. J.Chromatogr.A., 2011, 1218(19), 2722 – 2731.

8. Kolisnyk O.V. Development of control procedure for seneciphyline and other related impurities in platyphylline hydrotartrate substance and “Platyphylline-Zdorovie” injectable preparation by using RP HPTLC method. Pharmacom. 2015, 2, 59–67.

9. Rukovodstvo po validacii metodik analiza lekarstvennyh sredstv. Ed. N.V. Yurgel’, A.L. Mladencev, A.V. Burdeyn et al.; Developers V.L. Bagirova, A.I. Grizodub, T.H. Chibilyaev, D.A. Leont'ev, N.A. Lyapunov et al. Moscow: Farmacevticheskaya promyshlennost', 2007. P. 58.

10. Renkevich A.Yu., Kulikov A.Yu. Development and validation 4-aminobutyric acid assay in alendronate sodium tablets using micellar thin-layer chromatography. Methods and objects of chemical analysis. 2013, 8(4), 199–206.