scholarly journals Validated Reversed-Phase Liquid Chromatographic Method with Gradient Elution for Simultaneous Determination of the Antiviral Agents: Sofosbuvir, Ledipasvir, Daclatasvir, and Simeprevir in Their Dosage Forms

Molecules ◽  
2020 ◽  
Vol 25 (20) ◽  
pp. 4611
Author(s):  
Essam Ezzeldin ◽  
Nisreen F. Abo-Talib ◽  
Marwa H. Tammam ◽  
Yousif A. Asiri ◽  
Abd El-Galil E. Amr ◽  
...  

A simple, rapid, sensitive, and precise reversed-phase liquid chromatographic method was developed and validated for the simultaneous determination of four direct-acting antivirals, sofosbuvir (SF), ledipasvir (LD), declatasvir (DC), and simeprevir (SM), in their respective pharmaceutical formulations. Effective chromatographic separation was achieved on an Agilent Eclipse plus C8 column (250 mm × 4.6 mm, 5 µm) at 40 °C with gradient elution using a mobile phase composed of acetonitrile:phosphate buffer (pH 6.5). The quantification of SF and DC was based on peak area measurements at 260 nm, while the quantification of LD and SM was achieved at 330 nm. The linearity was acceptable from 1.0 to 20.0 μg/mL for the studied drugs, with correlation coefficients >0.999. The analytical performance of the newly proposed HPLC procedure was thoroughly validated according to ICH guidelines in terms of linearity, precision (RSD%, 0.39–1.57), accuracy (98.05–101.90%), specificity, limit of detection (LOD) (0.022–0.039 μg/mL), limit of quantification (LOQ) (0.067–0.118 μg/mL), and robustness. The validated HPLC method was successfully used to analyze the abovementioned drugs in their pure and dosage forms without interference from common excipients present in commercial formulations.

2007 ◽  
Vol 57 (2) ◽  
pp. 231-239 ◽  
Author(s):  
Mohamed Rizk ◽  
Fawzia Ibrahim ◽  
Mohamed Hefnawy ◽  
Jenny Nasr

Micellar liquid chromatographic analysis of benzyl alcohol and benzaldehyde in injectable formulationsAn accurate, sensitive and selective reversed-phase micellar liquid chromatographic method was developed for simultaneous determination of benzyl alcohol and benzaldehyde. This method was applied in different injectable formulations containing diclofenac, piroxicam, lincomycin and clindamycin. The method showed excellent linearity in the range of 10-100 μg mL-1and 1-20 μg mL-1with the limit of detection (S/N = 3) 0.25 μg mL-1(2.3 x 10-6mol L-1) and 0.12 μg mL-1(1.13 x 10-6mol L-1) for benzyl alcohol and benzaldehyde, respectively. The suggested method was successfully applied to the analysis of the studied drugs in bulk with average recoveries of 100.1 ± 1.0% for benzyl alcohol and 100.4 ± 1.6% for benzaldehyde, and to the determination of benzyl alcohol and benzaldehyde in injectable formulations with the respective average recoveries of 99.8 ± 0.3 and 100.0 ± 0.4%.


1991 ◽  
Vol 5 (2) ◽  
pp. 78-82 ◽  
Author(s):  
E. Mendez-Alvarez ◽  
R. Soto-Otero ◽  
G. Sierra-Paredes ◽  
E. Aguilar-Veiga ◽  
J. Galan-Valiente ◽  
...  

1992 ◽  
Vol 75 (1) ◽  
pp. 62-65 ◽  
Author(s):  
R Khazanchi ◽  
S Walia ◽  
S K Handa

Abstract A reversed-phase liquid chromatographic method has been developed for the determination of fenamiphos and the metabolites fenamiphos sulfoxide, fenamiphos sulfone, 3-methyl-4-(methylthlo)- phenol, and 3-methyl-4-(methylsulflnyl)phenol. Trace quantities of the nematlclde and Its metabolites In soil can be determined simultaneously. The limit of detection of the method was 5 ppm. Recoveries of fenamiphos and Its degradation products at fortification levels of 25,50, and 100 ppm ranged from 99.2 to 100.8%. Standard deviations ranged from 0.29 to 0.70 ppm.


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