RP-HPLC (STABILITY-INDICATING) BASED ASSAY METHOD FOR THE SIMULTANEOUS ESTIMATION OF DORAVIRINE, TENOFOVIR DISOPROXIL FUMARATE AND LAMIVUDINE

  • V L N Balaji Gupts Tiruveedhi Mr.
  • Venkateswara Rao Battula Andhra University, Visakhapatnam, Andhra Pradesh, India.
  • Kishore babu Bonige Andhra University, Visakhapatnam, Andhra Pradesh, India.

Abstract

Background:


In this study, a RP-HPLC (stability-indicating) based assay method for the estimation of doravirine (DRV), tenofovir disoproxil fumarate (TFF) and lamivudine (LMV) simultaneously in the tablets was described.


Methods:


The simultaneous analysis of DRV, TFF and LMV was done with HPLC system (Agilent 1100 series) and Luna Phenomenex C18 (250 mm × 4.6 mm × 5 μ) column with isocratic mobile phase (35% volume ratio of methanol and 65% volume ratio of 20 mM ammonium formate, pH 5). Validation of assay method was done on sensitivity, linearity, accuracy, selectivity, precision, robustness and specificity.  


Results:


The calibration curves were linear through the range of 25-200 µg/ml for DRV and 75-600 µg/ml for TFF and LMV.  The percent relative standard deviation for intraday variation/precision, interday variation/precision, intermediate precision/ruggedness and robustness were lower than 2%. The recovery of LMV (99.09-99.76%), TFF (99.10-99.41%) and DRV (98.65-99.28%) confirmed the good accuracy. The stability of LMV, TFF and DRV in 0.1N NaOH, 3% peroxide, 0.1 N HCl, UV light and dry heat of 60 oC was determined.


Conclusion:


The results have allowed the method to be implemented in tablets to quantify DRV, TFF, and LMV.

Keywords: Doravirine, Tenofovir disoproxil fumarate, Lamivudine, Stability, RP-HPLC

Author Biographies

Venkateswara Rao Battula, Andhra University, Visakhapatnam, Andhra Pradesh, India.

Professor, Department of Engineering Chemistry

Kishore babu Bonige, Andhra University, Visakhapatnam, Andhra Pradesh, India.

Assistant professor, Department of Engineering Chemistry,

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Tiruveedhi, V. L. N. B. G., Battula, V. R., & Bonige, K. babu. (2020). RP-HPLC (STABILITY-INDICATING) BASED ASSAY METHOD FOR THE SIMULTANEOUS ESTIMATION OF DORAVIRINE, TENOFOVIR DISOPROXIL FUMARATE AND LAMIVUDINE. International Journal of Applied Pharmaceutics, 13(1). Retrieved from https://innovareacademics.in/journals/index.php/ijap/article/view/39608
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