Abstract
Simultaneous Method Development and Validation of Fosamprenavir Calcium and Nevirapine by Reversed-Phase High-Performance Liquid Chromatography in Dendrimer-Carbon Nanotubes Conjugates
School of Pharmaceutical Sciences, 1School of Bioengineering and Biosciences, Lovely Professional University, Phagwara, Punjab 144411, India
Correspondence Address:
V. Mishra, School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab 144411, India, E-mail: vijaymishra2@gmail.com
The study was designed to develop a simple, precise, rapid and reproducible simultaneous method for fosamprenavir calcium and nevirapine in dendrimer-carbon nanotube conjugates. Reverse phase column C18 was used for the development and validation of the high-performance liquid chromatography method. The method was run on isocratic mode with methanol and water (80:20) with 1 ml/min flow rate and the detection was carried out at 258 nm. Fosamprenavir calcium was shown to have a retention time of 4.255 min whereas nevirapine had a retention time of 6.337 min. The method was validated as per International Council for Harmonisation M10 guidelines. The coefficient of correlation (R2) was found to be 0.9905 for fosamprenavir calcium and 0.9896 for nevirapine. The approach was accurate and precise based on drug recovery (greater than 95 %) and relative standard deviation (less than 2 % among duplicate experiments). Lower, medium and higher quantified concentration of fosamprenavir calcium were found to be 5.98 μg/ ml, 7.18 μg/ml and 8.38 μg/ml respectively and for nevirapine the lower, medium and higher quantified concentration were found to be 6.54 μg/ml, 7.74 μg/ml and higher quantified concentration 8.94 μg/ml respectively. Drug loading was found to be 47.59 % for fosamprenavir calcium and 69.65 % for nevirapine when both drugs are loaded together in dendrimer-carbon nanotube conjugates. From the study, it can be concluded that a robust method was developed that qualified different validation parameters and can be used for the determination of fosamprenavir calcium and nevirapine in dendrimer-carbon nanotube conjugates.
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