
Description:
Objective: 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 P
Results: The calibration curves were linear through the range of 25-200
henomenex C18 (250 mm
× 4.6 mm × 5 ?) column with isocratic mobile phase (35% volume ratio of methanol and 65% volume ratio of 20 mmol ammonium formate, pH 5).
Validation of assay method was done on sensitivity, linearity, accuracy, selectivity, precision, robustness and specificity.
µg/ml for DRV and 75-600 µg/ml for
Conclusion: The results have allowed the method to be implemented in the tablets to quantify DRV, TFF, and LMV.
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 °C was determined
Type:
Journal
Document:
Diploma III Farmasi
Date:
23-06-2024
Author:
V. L. N. BALAJI GUPTA TIRUVEEDHI