Abstract
Efavirenz is an anti-viral agent of non-nucleoside reverse transcriptase inhibitor category used as a part of highly active retroviral therapy for the treatment of infections of human immune deficiency virus type-1. A simple, sensitive and rapid reversed—phase high performance liquid chromatographic gradient method was developed and validated for the determination of efavirenz in plasma. The method was developed with high performance liquid chromatography using Waters X-Terra Shield, RP18 50 x 4.6 mm, 3.5 μm column and a mobile phase consisting of phosphate buffer pH 3.5 and Acetonitrile. The elute was monitored with the UV-Visible detector at 260 nm with a flow rate of 1.5 mL/min. Tenofovir disoproxil fumarate was used as internal standard. The method was validated for linearity, precision, accuracy, specificity, robustness and data obtained were statistically analyzed. Calibration curve was found to be linear over the concentration range of 1–300 μg/mL. The retention times of efavirenz and tenofovir disoproxil fumarate (internal standard) were 5.941 min and 4.356 min respectively. The regression coefficient value was found to be 0.999. The limit of detection and the limit of quantification obtained were 0.03 and 0.1 μg/mL respectively. The developed HPLC method can be useful for quantitative pharmacokinetic parameters determination of efavirenz in plasma.
Highlights
Efavirenz (EFV) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) and is used as part of highly active antiretroviral therapy (HAART) for the treatment of infections of human immunodeficiency virus (HIV) type 1 causing Acquired Immuno-Deficiency Syndrome (AIDS)
It can be observed that with the optimized chromatographic conditions shown in Table 2, the retention time was significantly reduced to 5.941 min in comparison to reported retention times in literature [11, 5, 6]
A good resolution was obtained between EFV and Tenofovir Disoproxil Fumarate (TDF) as internal standard with retention time 5.941 minutes and 4.356 min respectively
Summary
Efavirenz (EFV) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) and is used as part of highly active antiretroviral therapy (HAART) for the treatment of infections of human immunodeficiency virus (HIV) type 1 causing Acquired Immuno-Deficiency Syndrome (AIDS). EFV is one of the preferred NNRTI for treating HIV infection, for those HIV infections which previously has not been treated [1]. The current recommended first line of treatment is a NNRTI, EFV [2]. EFV is used in combination with other antiretroviral agents as part of an expanded post-exposure prophylaxis regimen to prevent HIV transmission for those exposed to materials associated with a high risk for HIV transmission [2].
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