Fixed dose combinations of ezetimibe and rosuvastatin are well known to provide significantly superior efficacy to rosuvastatin alone in lowering total cholesterol, and triglyceride levels. Therefore, in this recent work, we prepared fixed dose (10mg/10mg) ezetimibe and rosuvastatin tablet formulations, and a simple, selective and we established and validated rapid chromatographic method for the sensitive and simultaneous determination of rosuvastatin and ezetimibe. We performed the separation on Zorbax SB-C18 (100 mm x 4.6 mm, 3.5 µm particle size) column at 30 oC with a mobile phase that has a composition as water containing 0.1% H3PO4:methanol:acetonitrile (50:25:25 v/v/v) at 1.2 mL/min flow rate. We further performed validation studies according to ICH guidelines. Furthermore, we exposed rosuvastatin and ezetimibe to degradation conditions. We plotted peak area vs. concentration graphs for rosuvastatin and ezetimibe and used for defining the linearity of the detector response. In this suggested method, we observed linear relationships varying from 0.05 to 50 µg/mL for ezetimibe concentrations and from 0.05 to 25 µg/mL for rosuvastatin concentrations. We found the limit of detection values for rosuvastatin and ezetimibe as 0.006 and 0.008 µg/mL, respectively. Moreover, we further used the established method for to the analysis of ezetimibe and rosuvastatin from real spiked samples of rabbit serum.
Rosuvastatin Ezetimibe Liquid Chromatography Validation Stability Indicating Methods
ANKARA UNIVERSITESI
BAP 17B0237002
BAP 17B0237002
Birincil Dil | İngilizce |
---|---|
Konular | Analitik Kimya |
Bölüm | Makaleler |
Yazarlar | |
Proje Numarası | BAP 17B0237002 |
Yayımlanma Tarihi | 30 Ekim 2020 |
Gönderilme Tarihi | 31 Ağustos 2020 |
Kabul Tarihi | 13 Ekim 2020 |
Yayımlandığı Sayı | Yıl 2020 Cilt: 7 Sayı: 3 |