Development and validation of reversed-phase HPLC gradient method for the estimation of efavirenz in plasma

PloS One
Shweta GuptaAbdelwahab Omri

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 res...Continue Reading

References

Nov 17, 2001·Journal of Chromatography. B, Biomedical Sciences and Applications·M Saras-NacentaX Carné
Jul 16, 2003·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Bregt S KappelhoffJos H Beijnen
Apr 1, 2006·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Geetha RamachandranDavid J Greenblatt
Jul 13, 2016·JAMA : the Journal of the American Medical Association·Huldrych F GünthardPaul A Volberding

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