Abstract
AbstractA simple, selective and highly sensitive spectrofluorimetric method for the quantitative detection of an antiviral drug, daclatasvir (DCV) has been developed and analytically validated in its pure form, in its commercially available pharmaceutical preparations, and in hepatitis-C (HCV) patient’s plasma. The method was based on recording the native fluorescence of DCV that exhibit an emission wavelength maximum at 380 nm upon excitation at 320 nm. Many factors affecting the fluorescence intensity and the method sensitivity including pH, type of surfactant and solvent have been studied and optimized. In addition, a stability-indicating study was performed in accordance with the guidelines of the International Conference on Harmonization (ICH), to detect the drug in the presence of its degradation products which validates the method for application in quality control laboratories. In addition, extraction of DCV from the plasma proteins was performed using a simple technique that was based on using methanol and borate buffer (pH 9) that gave a recovery of ~95%. The results showed that DCV could be detected using this method in the pure form (with a linear range of 2-1000 ng/mL), commercially available tablets and in plasma samples (with a linear range of 5-1000 ng/mL), without any interferences. Furthermore, the method was also analytically and clinically validated according to the Food and Drug Administration (FDA) guidelines, with limit of detection (LOD) of 0.3 and 0.5 ng/mL for DCV in the pure form and plasma samples, respectively.
Highlights
Hepatitis-C virus (HCV) is a global health problem responsible for chronic infections for approximately 170 million people leading to 700 000 deaths [1]
According to the World Health Organization (WHO), the highest rate of HCV infection in the world has been recorded in Egypt where approximately 15% of its population have been diagnosed with HCV [2]; 150 000 Egyptians are carrying the latent virus and almost 40 000 people die every year [3,4]
DCV is combined with other drugs including SFB and RBV; any method developed for the assay must be able to determine DCV in the presence of such co-administrated drugs
Summary
Hepatitis-C virus (HCV) is a global health problem responsible for chronic infections for approximately 170 million people leading to 700 000 deaths [1]. Daclatasvir (DCV, Figure 1) is a DAA that was listed in the WHO Essential Medicines for the treatment of HCV and introduced into the global market in 2015 [8]. The application of such methods for the analysis of DCV in low socioeconomic countries, where HCV is an epidemic, is limited due to the high cost of operations and the rare availability of equipment. Most of these methods require well-trained staff, extensive extraction protocols and are time-consuming. This study describes a validated spectrofluorimetric method for the quantitative detection of DCV in its pure form, and which is commercially
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