title: A Validated Stability Indicating RP-HPLC Method for the Determination of Emtricitabine, Tenofovir Disoproxil Fumarate, Elvitegravir and Cobicistat in Pharmaceutical Dosage Form.
abstract: A new simple, rapid stability indicating assay method has been developed and validated for the determination of emtricitabine, tenofovir disoproxil fumarate, elvitegravir and cobicistat using reverse-phase high-performance liquid chromatography in their pharmaceutical dosage form. The chromatographic separation was performed on an ODS column (250 × 4.6 mm, 5 µm) using mobile phase A (potassium dihydrogen orthophosphate, pH adjusted to 2.5) and mobile phase B (acetonitrile) in the ratio of 55:45% v/v at a flow rate of 1 mL/min. The analytes were detected at 250 nm. The method was found to be linear in the concentration range of 2-12 µg/mL for EMT, 3-18 µg/mL for TNDF, 1.5-9 µg/mL for ELV and COB, with the coefficient value (R(2)) of >0.9990. The accuracy was measured via recovery studies and found to be acceptable, and the percentage recoveries were found in the range of 99.93-100.08 ± 0.5%. Forced degradation studies were also conducted, and the drugs were subjected to various stress conditions such as acid hydrolysis, base hydrolysis, oxidative, photolytic and thermal degradation. The proposed method was successfully validated and applied for the quantitative estimation of these drugs in both bulk and tablet dosage forms.
authors: Department of Pharmaceutical Chemistry, Joginpally B.R. Pharmacy College, Moinabad, Hyderabad 500 075, Telangana, India lalubpharm@gmail.com.
authors: Chinnalalaiah
authors: C
authors: Runja
authors: Aizant Drug Research Solutions, Hyderabad 500 014, Telangana, India.
authors: Pigili Ravi
authors: PR
authors: Kumar
authors: Department of Pharmacology, Bhaskar Pharmacy College, Moinabad, Hyderabad 500 075, Telangana, India.
authors: Srinivasa Rao
authors: SR
authors: Avanapu
mesh_terms: D019380:Anti-HIV Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D056148:Chromatography, Reverse-Phase / Q000379:methods*; D000069547:Cobicistat / Q000032:analysis*; D004304:Dosage Forms; D004355:Drug Stability; D000068679:Emtricitabine / Q000032:analysis*; D000068698:Tenofovir / Q000032:analysis*
chemical_list: D019380:Anti-HIV Agents; D004304:Dosage Forms; D000068698:Tenofovir; D000068679:Emtricitabine; D000069547:Cobicistat