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Inamadugu J.K.,Sri Venkateswara University | Inamadugu J.K.,Wellquest Clinical Research Laboratory | Damaramadugu R.,Sri Venkateswara University | Damaramadugu R.,Wellquest Clinical Research Laboratory | And 2 more authors.
Biomedical Chromatography | Year: 2010

A simple, sensitive and rapid method has been developed and validated for determination of the metoclopramide (MCP) in 100 μL human plasma. The analytical procedure involves a liquid-liquid extraction method using tramadol as an internal standard (IS). Chromatographic separation was carried out on a HyPURITY ADVANCE column using a mobile phase consisting of acetonitrile and 10 mM ammonium acetate buffer in the ratio of 80:20 (v/v) at a flow rate of 0.3 mL/min. The total run time of analysis was 2.5 min and elution of MCP and IS occurred at 0.9 and 1.3 min, respectively. A linear response function was established for the range of concentrations 0.53-42.07 ng/mL (r > 0.99). The intra- and inter-day precision values for MCP met the acceptance as per FDA guidelines. MCP was stable in a battery of stability studies viz., bench-top, auto-sampler and freeze-thaw cycles. The developed assay method was successfully applied to an oral bioequivalence study in humans. Copyright © 2010 John Wiley & Sons, Ltd. Source


Inamadugu J.K.,Sri Venkateswara University | Inamadugu J.K.,Wellquest Clinical Research Laboratory | Damaramadugu R.,Sri Venkateswara University | Damaramadugu R.,Wellquest Clinical Research Laboratory | And 2 more authors.
Biomedical Chromatography | Year: 2010

An LC-MS/MS method for the simultaneous quantitation of niacin (NA) and its metabolites, i.e. nicotinamide (NAM), nicotinuric acid (NUA) and N-methyl-2-pyridone-5-carboxamide (2-Pyr), in human plasma (1 mL) was developed and validated using nevirapine as an internal standard (IS). Extraction of the NA and its metabolites along with the IS from human plasma was accomplished using a simple liquid-liquid extraction. The chromatographic separation of NA, NAM, NUA, 2-Pyr and IS was achieved on a Hypersil-BDS column (150 x 4.6 mm, 5 μm) column using a mobile phase consisting of 0.1% formic acid : acetonitrile (20:80 v/v) at a flow rate of 1 mL/min. The total run time of analysis was 2 min and elution of NA, NAM, NUA, 2-Pyr and IS occurred at 1.37, 1.46, 1.40, 1.06 and 1.27 min, respectively. A detailed validation of the method was performed as per the FDA guidelines and the standard curves were found to be linear in the range of 100-20000 ng/mL for NA; 10-1600 ng/ mL for NUA and NAM and 50-5000 ng/mL for 2-Pyr with mean correlation coefficient of ≥0.99 for each analyte. The method was sensitive, specific, precise, accurate and suitable for bioequivalence and pharmacokinetic studies. The developed assay method was successfully applied to a pharmacokinetic study in humans. Copyright © 2010 John Wiley & Sons, Ltd. Source


Damaramadugu R.,Sri Venkateswara University | Damaramadugu R.,Wellquest Clinical Research Laboratory | Inamadugu J.,Sri Venkateswara University | Inamadugu J.,Wellquest Clinical Research Laboratory | And 3 more authors.
Chromatographia | Year: 2010

A simple, rapid, specific and sensitive method has been developed and validated for simultaneous determination of lopinavir and ritonavir in human plasma. The analytical procedure involves a protein precipitation method using fluoxetine as internal standard Separation was carried out on an Inertsil ODS column using a mobile phase consisting of acetonitrile and 5 mM ammonium acetate buffer. The total run time of analysis was 2.0 min. A linear response function was established for the range of concentrations 50.67-10,008.82 ng mL -1 for lopinavir and 5.066-1,000.693 ng mL -1 for ritonavir. The method was successfully applied to an oral bioequivalence study in humans. © 2010 Vieweg+Teubner Verlag | Springer Fachmedien Wiesbaden GmbH. Source

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