Abstract
An accurate and rapid reverse HPLC method has been developed and validated for the simultaneous quantification of lamivudine, nevirapine, and tenofovir disoproxil fumarate. Suitable separation was achieved on Phenomenex Synergi C18 (250 × 4.6 mm, 4 μm) using mobile phase, methanol (50%): ammonium acetate buffer (adjusted to pH 2.80) (40%): acetonitrile (10%) in an isocratic mode. The drugs were detected at 270 nm with a flow rate of 1.0 ml/min, and the retention times were found to be 3.26, 5.42, and 7.55 minutes for lamivudine, nevirapine, and tenofovir disoproxil fumarate, respectively. The developed method was validated per ICH guidelines. Good linearity was obtained within the concentration ranges of 10–59 µg/ml, 7–42 µg/ml, and 15–90 µg/ml with a correlation coefficient of not less than 0.990. The % RSD values for precision (intraday and interday) and accuracy studies were found to be less than 2%. The results obtained from quantitative analysis conform to USP content requirements for marketed tablet dosage forms, RICOVIR-LN, and tenofovir disoproxil fumarate/lamivudine tablets. The method is therefore useful for routine quality control of antiretroviral tablet dosage forms containing tenofovir disoproxil fumarate, lamivudine, and nevirapine.
Highlights
HIV/AIDS is a major public health issue and as such forms a significant part of the Sustainable Development Goals, with the aim of ensuring healthy lives and promoting well-being for all at all ages [1]. e introduction of highly active antiretroviral therapy (HAART), a treatment regimen comprising of the combination of three or more antiretroviral drugs [2], has revolutionized the management of the disease condition, with the resultant dramatic reduction in mortality rates and the incidences of opportunistic infections [3]
In as much as these methods have provided useful tools to assess the qualities of some ARVs, it is necessary that very efficient alternative methods with the target scope of ARVs in the HAART programme be developed to achieve similar quality control outputs. e aim of the current study was to develop a simple, affordable, and reliable method for the quality assessment of ARVs used in the HAART programme in Ghana and other parts of the world, where applicable
Standards and Samples. e working standards used for the study included confirmed 3TC, NVP, and tenofovir disoproxil fumarate (TDF) (Table 1), which were donated by Danadams Pharmaceutical Industry Limited, Spintex, Ghana. e drug products, samples A1 and A2 both claimed to be manufactured by Mylan Laboratories Limited, India, were used
Summary
HIV/AIDS is a major public health issue and as such forms a significant part of the Sustainable Development Goals, with the aim of ensuring healthy lives and promoting well-being for all at all ages [1]. e introduction of highly active antiretroviral therapy (HAART), a treatment regimen comprising of the combination of three or more antiretroviral drugs [2], has revolutionized the management of the disease condition, with the resultant dramatic reduction in mortality rates and the incidences of opportunistic infections [3]. In Ghana and other parts of the world, three of the widely used antiretrovirals (ARVs) in HAART include lamivudine (3TC), nevirapine (NVP), and tenofovir disoproxil fumarate (TDF). It may be argued that a lasting impact on morbidity and mortality on people living with HIV/AIDS (PLWHA) could be assured if the quality of ARVs was adequately monitored. In as much as these methods have provided useful tools to assess the qualities of some ARVs, it is necessary that very efficient alternative methods with the target scope of ARVs in the HAART programme be developed to achieve similar quality control outputs. E aim of the current study was to develop a simple, affordable, and reliable method for the quality assessment of ARVs used in the HAART programme in Ghana and other parts of the world, where applicable In as much as these methods have provided useful tools to assess the qualities of some ARVs, it is necessary that very efficient alternative methods with the target scope of ARVs in the HAART programme be developed to achieve similar quality control outputs. e aim of the current study was to develop a simple, affordable, and reliable method for the quality assessment of ARVs used in the HAART programme in Ghana and other parts of the world, where applicable
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