Introduction:

The focal intent of the current research work is to develop and validate a novel and reliable Stability indicating Reverse-Phase High performance liquid chromatographic (RP-HPLC) method for the simultaneous estimation of few Anti-Retrovirals i.e., Bictegravir, Emtricitabine and Tenofovir Alafenamide Fumarate.

Methods:

The novel method employs Inertsil Octyldecylsilyl (ODS) C18 (4.6 x 250mm, 5mm) using 0.2% Triethylamine (TEA) buffer and methanol in the ratio of 40:60 %v/v as mobile phase to attain the optimized elution. The Detection wavelength is 260 nm with 1.2 ml/min flow rate and 20 μl of injection volume.

Results:

Linearity ranges for Bictegravir, Emtricitabine & Tenofovir Alafenamide Fumarate were 25 - 125 μg/ml, 100 - 500 μg/ml, 12.5 - 62.5 μg/ml respectively. The Retention Times for Bictegravir, Emtricitabine and Tenofovir Alafenamide Fumarate are found to be 5.998 min, 2.805 min & 4.537 min respectively. Percent Recovery results of Bictegravir, Emtricitabine & Tenofovir AF were found within the range of 98 - 102% w/w.

Discussion and Conclusion:

The novel method was successfully validated as per ICH guidelines. Forced degradation studies are performed and based on the % degradation, Emtricitabine was found sensitive to Thermal conditions and the drugs Bictegravir & Tenofovir AF were found sensitive to Oxidative conditions. Based on the evaluation of obtained results, the developed method is economical and reliable for regular analysis concerning all validated parameters.

Keywords: Bictegravir, Emtricitabine, Tenofovir Alafenamide Fumarate, RP-HPLC, Validation, Forced degradation studies