Method Development And Validation For The Estimation Of Sofosbuvir By Reversed-Phase High Performance Liquid Chromatography
By: Mohsin Ali (2008-VA-586)
| Shaista Qamar.
Contributor(s): Dr. Nabeel Shahid | Dr. Abdul Muqeet Khan.
Material type: 
BookPublisher: 2016Description: 53p.Subject(s): Pharmaceutical Chemistry | Pharmaceutical SciencesDDC classification: 2593-T Dissertation note: Aim of the present work was to develop a UV/Visiblespectroscopic and isocratic reversed phase high performance liquidchromatography (RP-HPLC) method for estimation of Sofosbuvir, a novel drug molecule employed for the treatment of hepatitis C virus infection.Both of the methods were validated as per ICH guidelines.For UV/Vis method the solvent used was analytical grade methanol and maximum absorbance was obtained at wavelength 260 nm. The responsewas linear in range of 10 – 50 µg/ml with a regression coefficient of 0.999. For this method limit of detection (LOD) value and limit of quantification value were 0.25µg/ml and 0.84µg/ml respectively. The reversed phase chromatographic separation was achieved on a C18 column (5 µm,150 x 4.6 mm) in isocratic mode using mobile phase containing 0.1 % Phosphoric acid : Acetonitrile (60:40, % v/v) at ambient temperature (25°C). The pH of mobile phase was finally adjusted to 3.0 by using triethylamine. The flow rate was 1.0 ml/min and the detection was carried out at 260 nm and a sharp peak was obtained at retention time of 4.40 ± 0.01 min. The linear regression analysis data revealed that a good relationship occur between response and concentration in the range of 5 – 80 µg/ml. The regression coefficient was found out to be 0.999. The detection (LOD) and quantification (LOQ) limits as computed from peak to noise ratio was 0.50 µg/ml and 1.51 µg/ml.
It was proved from statistical analysis of results that data obtained by spectroscopic and chromatographic methods are highly accurate precise and reproducible and hence can beused for quality control and for further stability testing of Sofosbuvir.
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Thesis
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UVAS Library Thesis Section | Veterinary Science | 2593-T (Browse shelf) | Available | 2593-T |
Aim of the present work was to develop a UV/Visiblespectroscopic and isocratic reversed phase high performance liquidchromatography (RP-HPLC) method for estimation of Sofosbuvir, a novel drug molecule employed for the treatment of hepatitis C virus infection.Both of the methods were validated as per ICH guidelines.For UV/Vis method the solvent used was analytical grade methanol and maximum absorbance was obtained at wavelength 260 nm. The responsewas linear in range of 10 – 50 µg/ml with a regression coefficient of 0.999. For this method limit of detection (LOD) value and limit of quantification value were 0.25µg/ml and 0.84µg/ml respectively. The reversed phase chromatographic separation was achieved on a C18 column (5 µm,150 x 4.6 mm) in isocratic mode using mobile phase containing 0.1 % Phosphoric acid : Acetonitrile (60:40, % v/v) at ambient temperature (25°C). The pH of mobile phase was finally adjusted to 3.0 by using triethylamine. The flow rate was 1.0 ml/min and the detection was carried out at 260 nm and a sharp peak was obtained at retention time of 4.40 ± 0.01 min. The linear regression analysis data revealed that a good relationship occur between response and concentration in the range of 5 – 80 µg/ml. The regression coefficient was found out to be 0.999. The detection (LOD) and quantification (LOQ) limits as computed from peak to noise ratio was 0.50 µg/ml and 1.51 µg/ml.
It was proved from statistical analysis of results that data obtained by spectroscopic and chromatographic methods are highly accurate precise and reproducible and hence can beused for quality control and for further stability testing of Sofosbuvir.
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