Micellar high performance liquid chromatographic method for separation and validation of two anti-hepatitis C- virus drugs in pure form, human plasma and human urine.

OBJECTIVES

In the present study, an eco- friendly micellar liquid chromatographic technique was validated for separation and quantification of two drugs; namely ribavirin (RIV), and sofosbuvir (SBV) in pure form, pharmaceuticals containing them, human plasma and human urine. These drugs are administered co-administered for treatment of Hepatitis C virus (HCV) that causes hepatitis C in humans.

MATERIAL AND METHODS

These drugs were separated using Nucleosil 100-5 phenyl column. Sodium dodecyl sulphate (SDS) solution (0.05M, pH 7.0) containing triethylamine (0.3%) and n-butanol (10%) was used as a mobile phase with 1.2 mLmin flow rate and 215nm detection wavelength. Nine minutes were required for resolving the two drugs from the matrix.

RESULTS

The method showed good linearity for RIV and SBV with correlation coefficients (r) more than 0.9996 within the concentration ranges of (20-400) and (40-400) ngmL in pure form, (30-300) and (50-300) ngmL in human plasma and (20-400) and (40-400) ngmL in human urine, respectively.

CONCLUSION

The recommended method was applied for examination of RIV and SBV in pure and pharmaceuticals. The obtained results were statistically matched with reported methods with no significant differences. Also, the recommended method was effectively applied for estimation of both drugs in spiked human urine and plasma without purification or extraction steps and real samples of plasma and urine of humans having therapy of RIV and SBV, as well as, performing tablets dissolution-rate tests with satisfactory results.