Stability Indicating RP-UPLC Method for Simultaneous Estimation of Emtricitabine, Tenofovir and Bictegravir in Bulk and Pharmaceutical Dosage Form

Pharmaceutical Science-Pharmaceutical analysis for Novel drug formulation

Abstract

The Proposed Sensitive, specific, Linear, accurate, precise and Robust method was developed for the simultaneous estimation of the Emtricitabine, Tenofovir Alafenamide and Bictegravir in bulk and   Pharmaceutical tablet dosage form by Ultra performance liquid Chromatography. For the Optimised method, Chromatogram was run through AcquityBEH (Bridged Ethylene hybrid) C18  130A° (100mm ×2.1 mm, 1.7µm) column at a flow rate of 0.5 mL/min and pH 3.0 buffer Triethylamine(TEA) was used in this method. The Column oven temperature was maintained at 40 °C and the working wavelength was selected at 280 nm. The retention time of Emtricitabine, Tenofovir Alafenamide and Bictegravir were found to be 2.6 min, 4.3 min and 5.2 min respectively. The percentage RSD (Relative standard deviation) of the  method precision  for Emtricitabine,  Tenofovir Alafenamide  and Bictegravir  were  found to be  0.31%, 0.02%  and 0.17%  respectively. Percentage  Recovery  was  obtained  as  99.8%,  100.2%  and  100.7%  for  Emtricitabine,  Tenofovir  Alafenamide  and  Bictegravir  respectively. Linearity was obtained as 0.999, 0.999 and 0.999 for Emtricitabine, Tenofovir, Alafenamide and Bictegravir respectively. Analytical Range was found from the linearity and accuracy for Emtricitabine was 100 µg/mL to 300µg/mL, Tenofovir Alafenamide was 12.5µg/mL to 37.5 µg/mL and Bictegravir was 25µg/mL to 75µg/mL. Method is stability indicating because in forced degradation studies all main analytes peak purities were passed and no blank and Placebo interferences at the retention time of the main analytes. Thus the present method was developed by using low-cost solvent in ratio of TEA buffer pH 3.0.: Methanol (45:55 v/v), detected by using photodiode array detector which was highly sensitive to detect at a lower concentration. The use of mobile phase as an extracting solvent makes it more compatible with the developed method. So the proposed research method was sensitive, specific, accurate, precise, linear, and robust and this method can be used for routine and stability analysis in quality control for reduction of time and cost. The existing methods were not cost effective due to the use of highly sophisticated detectors, Expensive (high cost) solvents such as Tetrahydrofuran and some methods were found to be less sensitive.