Simple chromatographic and spectrophotometric determination of sofosbuvir in pure and tablet forms

Abstract

Two methods, a reversed phase high-performance liquid chromatographic (RP-HPLC) method and a direct ultra-violet spectrophotometric method, were adopted and validated for the quantification of sofosbuvir, which is a new antiviral agent used for treatment of patients with hepatitis C virus (HCV). Validation parameters such as linearity, accuracy, precision, specificity, limits of detection and quantification were determined according to the guidelines of International Conference on Harmonization (ICH)-Q2B. The RP-HPLC method was applied on Hypersil TM ODS C18 column (150×4.6 mm, 5 µm) as a stationary phase. The mobile phase was optimized according to the polarity of the studied drug. It was methanol: acetonitrile (90:10, v:v), pumped using an isocratic mode with flow rate of 1 mL/min and UV detection at 260 nm. The UV spectrophotometric method was performed for the studied drug at 260 nm. The calibration curves were linear in the ranges of 2-60 µg/mL and 5-40 µg/mL for the RP-HPLC and UV spectrophotometric methods, respectively. The proposed methods are accurate, sensitive and precise, so they can be successfully adopted for the reliable determination of sofosbuvir content in its tablet form.

Development and validation of a simple and rapid UPLC method for the in-vitro estimation of (-)-epigallocatechin-3-gallate in lipid-based formulations

“…The peak area ratio (PAR) of EGCG/caffeine was plotted versus EGCG concentration. Linearity was assessed by computing the best fitting line equation and the coefficient of determination (r 2 ) between the nominal concentrations added and the measured PARs by linear regression data analysis [31][32][33].…”

Validated simultaneous spectrophotometric quantification of a new antiviral combination

“…The results obtained by adopting the proposed methods for determination of pure SFV and LDI samples were statistically compared to those obtained by reference reported methods [6,8] as shown in Table 4. The comparison declares that, there is no significant difference between the proposed methods and the reference reported methods which confirm the accuracy and precision of the proposed methods.…”

“…The results obtained by applying the proposed procedures for determination of pure SFV and LDI samples were statistically compared to those obtained by reference reported methods [6,8] to ensure accuracy and precision of the suggested methods.…”

“…A fixed-dose combination of SFV and LDI was approved by food and drug administration (FDA) for the treatment of patients infected with genotype 1HCV [4]. Referring to the literature, SFV was determined using chromatographic and spectrophotometric techniques [5,6]. Also, SFV forced degradation was studied using liquid chromatography-tandem mass spectrometry (LC-MS/MS) [7].…”

Development of a highly sensitive high‐performance thin‐layer chromatography method for the screening and simultaneous determination of sofosbuvir, daclatasvir, and ledipasvir in their pure forms and their different pharmaceutical formulations

“…SFS is a pan‐genotypic inhibitor of HCVNS5B RNA‐dependent RNA polymerase, which is essential for viral replication, SFS is nucleotide prodrug which is converted to active uridine analog triphosphate (GS 461203) by intracellular metabolism . Different analytical methods were reported for determination of SFS including spectrophotometry , HPLC–UV , HPLC–MS , UHPLC–MS/MS , and high‐performance thin layer chromatography (HPTLC) . Daclatasvir (DAC), Figure , is chemically methyl [(2 S )‐1‐{3‐[5‐{4′‐[2‐{1‐[(methoxycarbonyl)‐ l ‐valyl]pyrrolidin‐2‐yl}‐1 H ‐imidazol‐5‐yl]‐(1,1′‐biphenyl)‐4‐yl}‐1 H ‐imidazol‐2‐yl]pyrrolidin‐1‐yl}‐3‐methyl‐1‐oxobutan‐2‐yl]carbamate.…”