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Development and Application of Liquid Chromatographic Method for Simultaneous Determination of Elvitegravir, Tenofovir Disoproxil Fumarate, Emtricitabine, and Cobicistat in Fixed Dosage Form

Submitted by webadmin on Wed, 10/19/2016 - 10:57
Pharmaceutical Methods,2014,5,1,7-13.
Published:january 2014
Type:Original Article

Development and Application of Liquid Chromatographic Method for Simultaneous Determination of Elvitegravir, Tenofovir Disoproxil Fumarate, Emtricitabine, and Cobicistat in Fixed Dosage Form

Raghu Ram Jampala1, V. Kiran Kumar2, Appala Raju Nemala3*

1Department of Pharmacology, Sultan-ul-Uloom College of Pharmacy, Banjara Hills, Hyderabad, Andhra Pradesh, India,

2Department of Pharmaceutical Analysis, Unity College of Pharmacy, Raigiri, Bhongir, Nalgonda District, Andhra Pradesh, India,

3Department of Pharmaceutical Chemistry, Sultan-ul-Uloom College of Pharmacy, Banjara Hills, Hyderabad, Andhra Pradesh, India

Abstract:

Introduction: Quad pill is fixed-dose combinations containing four drugs in a single tablet with the intention of reducing the number of tablets that need to be taken. Elvitegravir/ Cobicistat/ Emtricitabine/ Tenofovir disoproxil fumarate (“QUAD”) – is a complete regimen intended for treatment of HIV infection. Developing a single analytical method for the estimation of individual drugs in a quad pill is very challenging, due to the formation of drug-drug and drug-excipient interactions. Method: Chromatographic separation of the four antiviral drugs was achieved by using a gradient elution at a flow rate of 1.0 mL/min on Inertsil ODS 3V C18 column (250 m×4.6 mm, 5 μm particle size, 100Å pore size) at ambient temparature. Mobile phase A of the gradient solvent system was KH2PO4 (0.02M) in 1000 ml of water and by adjusting the pH to 2.5 with dilute orthophosphoric acid and mobile phase B was acetonitrile. UV detection at 240nm was employed to monitor the analytes. Results: A linear response was observed for emtricitabine over the concentration range 20-240 μg/mL, for tenofovir disoproxil fumerate over the concentration range of 30-360 μg/mL, for elvetegravir and cobicistat over the concentration range of 15-180 μg/mL. Limit of detection (LOD) for emtricitabine, Tenofovir disoproxil fumerate, elveltegravir and cobicisate were 0.02μg/ mL, 0.03μg/mL, 0.75μg/mL and 3μg/mL respectively. Limit of quantification (LOQ) for emtricitabine, Tenofovir disoproxil fumerate, elveltegravir and cobicisate were 0.06μg/mL, 0.09μg/mL, 2.25μg/mL and 9μg/mL respectively. Conclusion: The present study demonstrates the applicability of chromatographic method to develop a new, sensitive, single HPLC method for the simultaneous quantitative determination of four antiviral agents in fixed pharmaceutical dosage form.

Chemical structures of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate