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Development and validation of HPLC methods for simultaneous analysis of 6 antiretrovirals in pharmaceutical formulatio


Journal of Analytical & Pharmaceutical Research
Mankulu Kakumba Jocelyn,1 Muhindo Mahamba Augustin,1,2 Mbenza Puati Adelard,1 Mbinze Kindenge Jeremie,1 Kimbeni Malongo Tresor1

Abstract

Background: HIV/AIDS stills one of the world’s most significant public health problems, affecting particularly Africa. Hence, there is a need to dedicate more attention to fight against HIV by promoting the use of appropriate medicines for its treatment.

Introduction: Unfortunately, the quality of these medicines is currently a deep concern in the public health sector due to the issue of drugs counterfeiting. Therefore, developing a screening and quantitative high-performance liquid chromatography method to simultaneously analyze 6 antiretrovirals (ARVs) from the same matrix (excipients) can be considered as a commendable breakthrough towards improved quality control of ARV.

Methods: Many specific methods dedicated to ARV analysis in different dosage forms have been previously developed; some of them were predicted and optimized. In this study, we have developed and validated a rapid and affordable method using short column and low cost organic solvent (Methanol) in gradient mode, which seems to be very practical in the Africa context. In addition, we verified our method ability for analysis of various fixed-dose combinations made of FTC/TDF/EFV (two different batches); 3TC/ZDV (one batch) and ZDV/NVP (one batch) in tablets formulations. The validation results satisfied the fixed specifications, then the method was applied to test unknown four4 samples (1;2; 3 and 4) that were claimed to contain the targeted ARV.

Results: The results obtained with all the samples were encouraging and suggested that samples 2 and 4 contained the same ARV as predicted at the beginning of experiment. The developed analytical method appears to be promising for routine analysis of ARV formulations, allow tackling the issue of HIV product counterfeiting.

Keywords

development, validation, quality control, high performance liquid chromatography, anti-retrovirals, muscle relaxant, methanol and trifluoroacetic acid

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