alexa Chromatographic Analysis Of Ledipasvir And Sofosbuvir: New Treatment For Chronic Hepatitis C Infection With Application To Human Plasma
ISSN: 2157-7064

Journal of Chromatography & Separation Techniques
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4th World Congress on Chromatography
August 07-09, 2017 | Rome, Italy

Nehal Farid
Beni-Suef University, Egypt
Posters & Accepted Abstracts: J Chromatogr Sep Tech
DOI: 10.4172/2157-7064-C1-032
Abstract
A RP-HPLC/DAD method was developed and validated for the first time for the analysis of the newly formulated anti-HCV combination, in pure form, pharmaceutical formulation and in human plasma. In the developed method separation was carried out on Zorbax® Eclipse C18 column using a gradient mixture of acetonitrile: water as a mobile phase and scanning was performed at 260 nm (for SOF) and 330 nm (for (LED). The two drugs were completely separated from each other and from plasma, where plasma peak appeared at 2.76±0.05 min, SOF at 4.25±0.05 and LED at 7.35±0.05. The developed method showed high sensitivity, the drugs showed linearity in the range of 1-45 μg/mL for both pure form and spiked human plasma. Three freeze-thaw cycles were carried out separately at two different temperatures, -8oC and -20oC. No significant loss of the studied drugs was observed during repeated thawing and freezing. Validation parameters such as accuracy, precision, robustness and ruggedness were tested in compliance with USP recommendations, where acceptable results were obtained. Applying to pharmaceutical formulation showed no interference from tablet excipients.
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