Hitesh Patel, Nikunj Patel, Priyanka Shah, Rohit Gajera
A simple, rapid, precise
and accuratereversed phase HPLC stability indicating method was developed for
simultaneous determination ofemtricitabine (ECT), dolutegravir (DOL) and tenofovir
alafenamide(TEN) in their combined dosage marketed formulation. The chromatographic
separation was achieved on Hypersil BDS C18(250´
4.6 mm, 5.0 µ) columnusing
0.5 M potassium dihydrogen phosphate buffer:acetonitrile(80: 20, v/v), pH 3.5 ±
0.1 maintained by 0.1 % o-phosphoric acid as mobile phaseat a
flow rate of 1.0 mL/min and monitored at 260 nm. All three analytes were resolved
at retention times of 5.777, 6.783, 8.393 min for ECT, DOL, and TEN respectively.The
assay performance of the present developed method was validated for various
parameters like system suitability, linearity, accuracy, precision, robustness,
limit of detection and quantification. The calibration curves were linear over concentration
ranges of 12.5-75.0, 50.0-300, and 6.25-37.5 μg/ml for DOL, ECT, and TEN,
respectively with correlation coefficients ³ 0.9995.All three analytes were subjected to various
stress conditions of hydrolysis, oxidation, photolysis and thermal
degradation. Considerable degradation was found in alkaline condition. The present
method demonstrated to be effective stability-indicating by resolution of the
analytes from their forced-degradation products. The validated method was
successfully applied for the simultaneous estimation three drugs in their combined
pharmaceutical dosage formSpegraÒ.
Emtricitabine,
Dolutegravir, Tenofovir, Stability indicating, HPLC, Validation, Forced degradation,
Pharmaceutical tablets
VOL.13, ISSUE No.3, September 2021