Abstract

DEVELOPMENT & VALIDATION OF RELATED SUBSTANCES METHOD FOR ESTIMATION OF IMPURITIES OF EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE & EFAVIRENZ IN FIXED DOSE TABLET FORMULATION BY RP-HPLC.

Bhavesh H. Patel*

ABSTRACT

Human immunodeficiency virus infection and acquired immunodeficiency syndrome (HIV/AIDS) is a spectrum of conditions caused by infection with the human immunodeficiency virus (HIV) a retrovirus. The drugs, Emtricitabine (EMT), Tenofovir disoproxil fumarate (TDF) & Efavirenz (EFV) have potential to manage cited disease. These molecules also have some unwanted substances in finished dosage form which may deteriorate the active ingredients in the fixed dose tablet formulation. Therefore, the attempt was made to estimate impurities of mentioned drugs by RP-HPLC method. During method development and validation, Waters HPLC was used with PDA detector and auto injector module to perform analysis of samples. The mobile phase was finalised 20mM phosphate buffer pH-3.0±0.05 as a mobile phase-A and acetonitrile: methanol (90:10 %v/v) as a mobile phase-B. Samples were injected in C18 column (Waters Sunfire C18 250×4.6 mm; 5 μm) which was eluted at 1.0 mL/min. The Linearity was determined at six concentration levels from LOQ to 150% of specification limit of sample preparation (i.e., 400 μg/mL of EMT, 600 μg/mL of TDF and 1200 μg/mL of EFV). Several impurities, nine (09) were subjected to analyse with drugs substances as per ICH guideline. The method was developed to be accurate, precise and robust and has potential to analyse the drugs and related substances qualitatively and quantitatively. The proposed method is selective and sensitive to estimate the drugs and impurities from bulk and pharmaceutical dosage forms in IPQC department would address stability of formulations.

Keywords: HPLC, Anti viral drugs, Related substances, PDA detector.