DEVELOPMENT AND VALIDATION OF STABILITY INDICATING SIMULTANEOUS UVSPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE, COBICISTAT, AND ELVITEGRAVIR IN PURE AND PHARMACEUTICAL DOSAGE FORM

Stability-Indicating HPLC Method for the Simultaneous Determination of HIV Tablet Containing Emtricitabine, Tenofovir Disoproxil Fumarate, and Rilpivirine Hydrochloride in Pharmaceutical Dosage Forms

A simple, accurate, rapid, and stability-indicating RP-HPLC method for a combination of tenofovir disoproxil fumarate, emtricitabine, and rilpivirine has been developed and subsequently validated in commercial tablets. The proposed HPLC method utilizes Phenomenex Gemini C18 column (150 mm × 4.6 mm i.d., 5 µm) and mobile phase consisting of MeCN, potassium dihydrogen phosphate buffer (20 mM, pH ...

AusPAR Attachment 2: Extract from the Clinical Evaluation Report for Tenofovir disoproxil fumarate/Emtricitabine/Elvitegravir/Cobicistat

Randomized, phase 2 evaluation of two single-tablet regimens elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for the initial treatment of HIV infection.

OBJECTIVE To assess the safety and efficacy of two, single-tablet regimens for the initial treatment of HIV infection. DESIGN Phase 2, randomized, double-blind, double-dummy, multicenter, active-controlled study. METHODS Antiretroviral treatment-naive adults with a screening HIV-1 RNA at least 5000 copies/ml and a CD4 cell count more than 50 cells/μl were randomized 2: 1 to receive fixed-do...

Evaluation of tolerability with the co-formulation elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate for post-HIV exposure prophylaxis

BACKGROUND The preferred regimen for HIV post-exposure prophylaxis (PEP) is based mainly on safety and tolerability because it is given to immunocompetent people without HIV infection for a limited time (28 days). The frequency of adverse events (AEs) may be > 60%. Although AEs are generally not severe, they can lead to lack of adherence and failure to complete the regimen. We evaluated the co-...

HPTLC-densitometry method development and validation for simultaneous determination of abacavir, lamivudine and zidovudine in combined dosage form

A simple, accurate and precise HPTLC- densitometry method for the simultaneousdetermination of abacavir, lamivudine and zidovudine in pharmaceutical tablet has beendeveloped. Separation of tablet components was performed on aluminum backed HPTLC plates(silica gel 60 F254 20×20 cm with 0.2 mm thickness, Camag, Muttenz, Switzerland ) usingmethanol : chloroform : acetonitrile (4 : 8 : 3 v/v). Good...