Development and Validation of a Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) Dissolution Method for the Simultaneous Quantification of Emtricitabine and Tenofovir Alafenamide in Tablet Formulations

Shankar Sahebrao Yelmame^1* and Sunil Vishvanath Amrutkar²

¹Department of Pharmaceutical Chemistry, SNJB’s Shriman Sureshdada Jain College of Pharmacy, Jain Gurukul, Neminagar, Chandwad, Dist- Nashik, Maharashtra, India.

²Department of Pharmaceutical Chemistry, Gokhale Education Society’s, Sir Dr. M. S. Gosavi College of Pharmaceutical Education and Research Centre, Nashik, Maharashtra, India.

Corresponding Author E-mail: shankar.yelmame@gmail.com

ABSTRACT: Reversed Phase-High Performance Liquid Chromatography (RP-HPLC) is an isocratic method that is simple, specific, accurate, fast, and inexpensive. It was created and approved for the quantitative measurement of tenofovir alafenamide and emtricitabine in pharmaceutical tablet dosage forms. An in vitro dissolving study of tablets containing the aforementioned medications was conducted using the HPLC method. Phenomenex C18 (250 mm X 4.6 mm, 5 µm) was used in the development of the RP-HPLC technique. Methanol and water made up the mobile phase (65:35% v/v). The UV-Vis detector was used to monitor the responses at 216 nm while a flow rate of 1.0 mL/min was used. With a USP Apparatus II at 37°C and 500 mL of 50 mM Sodium Citrate buffer (pH 5.50) as the dissolution medium, the dissolution test was carried out at 75 rpm. It was discovered that the retention periods for EMT and TNF were 3.13 and 4.82 minutes, respectively. EMT (correlation coefficient 0.99998) in the 10–150 µg/mL range and TNF (correlation coefficient 0.99994) in the 1.25–18.75 µg/ml range were found to be linear. Limit of detection, limit of quantitation, precision, accuracy, robustness, specificity, and linearity were all validated. The proposed method is suitable for routine quality control.

KEYWORDS: Dissolution; Emtricitabine (EMT); Isocratic; Method Validation; RP-HPLC; Tenofovir Alafenamide (TNF)

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