LIQUID CHROMATOGRAPHIC QUANTIFICATION OF TERNARY MIXTURE OF ANTI-VIRAL DRUGS AND APPLICATION TO ASSESSMENT OF THEIR TABLET DOSAGE FORM

  • Anumolu P. D. Osmania University
  • Anusha K. Osmania University
  • Mrudula Kiran A. Osmania University
  • Monika P. Osmania University
  • Sowndarya Nskr Osmania University
  • Sunitha G. Gokaraju Rangaraju College of Pharmacy, Department of Pharmaceutical Analysis and Quality Assurance, Osmania University, Hyderabad 500090, Telangana state, India

Abstract

Objective: To establish a validated liquid chromatographic method for the quantification of Tenfovir disoproxil fumarate (TENO), Lamivudine (LAM) and Nevirapine (NEV) in ternary combination and in its tablet dosage form.

Methods: The three drugs were well resolved using ODS C18 column (250 x 4.6 mm, 5μm) with a mobile phase consisting of phosphate buffer, pH 3.0-acetonitrile (60:40, v/v) with a flow rate of 1.0 mL/min at UV detection wavelength 252 nm. The developed method was validated as per ICH guidelines.

Results: The response was a linear function of analyte concentration over the concentration range of 45-105 µg/ml for tenofovir disoproxil fumarate, lamivudine and between 30-70 µg/ml for nevirapine with a correlation coefficient>0.9997. The % RSD values of precision and accuracy studies were found to be less than 2.

Conclusion: The proposed method was validated as per standard guidelines. The results obtained from assay values were in good agreement with the labeled amount of the marketed tablet dosage form RICOVIR-LN. The method holds promise for routine quality control of this ternary combination in bulk and pharmaceutical formulations.

 

Keywords: Column liquid chromatography, Tenofovir Disoproxil Fumarate, Lamivudine, Nevirapine

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References

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P. D., A., A. K., M. K. A., M. P., S. Nskr, and S. G. “LIQUID CHROMATOGRAPHIC QUANTIFICATION OF TERNARY MIXTURE OF ANTI-VIRAL DRUGS AND APPLICATION TO ASSESSMENT OF THEIR TABLET DOSAGE FORM”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 8, no. 1, Nov. 2015, pp. 237-40, https://innovareacademics.in/journals/index.php/ijpps/article/view/6257.
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