Abstract
Objective: The objective of the study was to develop a novel, simple, sensitive, accurate, precise, and stability-indicating reverse-phase (RP) liquid chromatographic method for simultaneous estimation of sofosbuvir and daclatasvir in pure and pharmaceutical formulation.
 Methods: In the present work, chromatographic separation was done using stationary-phase discovery column (250 mm×4.6 mm; 5 μm particle size) and mobile phase consisting of 0.1N potassium dihydrogen orthophosphate buffer:acetonitrile (55:45, v/v), with the flow rate of 1 ml/min, and the detection of column effluents was achieved with photodiode array at 260 nm.
 Results: The retention time of sofosbuvir and daclatasvir was found to be 2.32 min and 3.06 min, respectively. Stability-indicating studies were conducted according to the guidelines of International Conference on Harmonization (ICH) Q1A R2, and validation of the method was done as per the ICH guidelines Q2R1. The linearity of the method was in the concentration range of 100–600 μg/ml and 15–90 μg/ml for sofosbuvir and daclatasvir, respectively. The correlation coefficients were found to be 0.9996 and 0.9996 for sofosbuvir and daclatasvir, respectively. The limit of detection and limit of quantification were found to be 0.19 μg/ml and 0.59 μg/ml for sofosbuvir and 0.02 μg/ml and 0.05 μg/ml for daclatasvir, respectively.
 Conclusion: The stability-indicating RP high-performance liquid chromatographic (RP-HPLC) method was novel, simple, precise, accurate, and sensitive for simultaneous estimation of sofosbuvir and daclatasvir in pure and pharmaceutical formulations. Hence, the developed method was adopted for qualitative and quantitative analysis of sofosbuvir and daclatasvir in pure and pharmaceutical formulations.
Highlights
Hepatitis is a kind of liver disease, and various forms of liver diseases are hepatitis A virus, hepatitis B virus, hepatitis C virus (HCV), hepatitis D virus, hepatitis E virus, and liver cirrhosis [1,2]
The development trails were conducted based on the chemical nature of sofosbuvir and daclatasvir
Mobile phase was selected based on polarity of functional groups present in sofosbuvir and daclatasvir
Summary
Hepatitis is a kind of liver disease, and various forms of liver diseases are hepatitis A virus, hepatitis B virus, hepatitis C virus (HCV), hepatitis D virus, hepatitis E virus, and liver cirrhosis [1,2]. Sofosbuvir (GS7977/PSI-7977) is a nucleotide HCV NS5B polymerase inhibitor. It is a prodrug of 2-deoxy-2-fluoro-2-C-methyluridine, which is converted to its active form within hepatocytes. Sofosbuvir chemically called as (S)-isopropyl-2-{[(S)-{[(2R,3R,4R,5R)5-{2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy4-methyltetrahydrofuran-2-yl) methoxy–(phenoxy) phosphoryl amino) propanoate [3,4,5]. Daclatasvir is chemically called as methyl N-[(2S)-1-[(2S)-2-[5-[4-[4-[2[(2S)-1-[(2S)-1-(2S)-2-(methoxy carbonyl amino)-3-methyl butanoyl] pyrrolidin-2-yl]-1H-imidazol-4-yl]-4-biphenylyl]-1H-imidazol-2-yl] pyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl]carbamate. Daclatasvir and Sofosbuvir combination had shown 90% SVR (Sustained virological response) rates for 12 weeks in patients without cirrhosis [6,7,8,9]
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