Development and Validation of a New Stability Indicating RP-UPLC Method for the Simultaneous Estimation of Anti-Viral Drugs: Tenofovir Disoproxil Fumarate, Emtricitabine and Dolutegravir (Tablets)
Bandaru Sai Pavan Kumar and Mukthinuthalapati Mathrusri Annapurna*
Department of Pharmaceutical Analysis, GITAM School of Pharmacy, Gandhi Institute of Technology and Management (Deemed to be University), Visakhapatnam, India
*Corresponding Author: Mukthinuthalapati Mathrusri Annapurna, Department of Pharmaceutical Analysis, GITAM School of Pharmacy, Gandhi Institute of Technology and Management (Deemed to be University), Visakhapatnam, India.
September 30, 2022; Published: October 27, 2022
Emtricitabine, Tenofovir disoproxil fumarate and Dolutegravir sodium are anti-HIV drugs. The authors have developed a new stability indicating RP-UPLC method for the simultaneous determination of Emtricitabine, Tenofovir disoproxil fumarate and Dolutegravir sodium in tablets on gradient mode using a mixture of mobile phase A (0.1% Tri ethyl amine pH adjusted to 4.5 ± 0.05 with ortho phosphoric acid) and mobile phase B (0.1% Tri fluoro acetic acid in acetonitrile) with 1.0 mL/min flow rate are the chromatographic conditions for the entire study. Shimadzu NexeraX2 Model UPLC system with PDA detector Zorbax column (100 mm × 4.60 mm, 3.5 μ) was employed for the present study. Beer-Lambert’s law was obeyed over the concentration range 2-600, 2-900 and 1-150 µg/mL with linear regression equation y = 1226.8x - 160.82 (R² = 0.9999), y = 1200.3x - 1540.5 (R² = 0.9999) and y = 3214x + 693.63 (R² = 0.9999) for Emtricitabine, Tenofovir disoproxil fumarate and Dolutegravir sodium and the method was validated as per ICH guidelines. The LOQ values were found to be 1.8231, 1.9014 and 0.9243 µg/mL and that of LOD values as 0.6002. 0.6259 and 0.3039 µg/mL for Emtricitabine, Tenofovir disoproxil fumarate and Dolutegravir sodium respectively. The combination of Tenofovir Disoproxil Fumarate, Dolutegravir sodium and Emtricitabine was exposed to various stress conditions and the stability of the proposed method was carried out at UV detection 260 nm. The proposed RP-UPLC method is simple, precise, accurate, robust and used for the routine analysis of tablet dosage forms.
Keywords: UPLC; Stability Indicating; Emtricitabine; Tenofovir Disoproxil Fumarate; Dolutegravir Sodium
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