Macleods Pharmaceutical Ltd.

Mumbai, India

Macleods Pharmaceutical Ltd.

Mumbai, India

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Deshpande A.Y.,Macleods Pharmaceutical Ltd. | Gurav S.,Macleods Pharmaceutical Ltd. | Punde R.,Macleods Pharmaceutical Ltd. | Zambre V.,Macleods Pharmaceutical Ltd. | And 4 more authors.
Biomedical Chromatography | Year: 2011

A highly sensitive and specific LC-MS/MS method has been developed for simultaneous quantification of ethionamide and ethionamide sulfoxide in human plasma (300μL) using prothionamide as an internal standard (IS). Solid-phase extraction was used to extract ethionamide, ethionamide sulfoxide and IS from human plasma. The chromatographic separation of ethionamide, ethionamide sulfoxide and IS was achieved with a mobile phase consisting of 0.1% acetic acid:acetonitrile (20:80, v/v) at a flow rate of 0.50mL/min on a Peerless Basic C18 column. The total run time was 3.5min and the elution of ethionamide, ethionamide sulfoxide and IS occurred at 2.50, 2.18 and 2.68min, respectively. A linear response function was established for the range of concentrations 25.7-6120ng/mL (r > 0.998) for ethionamide and 50.5-3030ng/mL (r > 0.998) for ethionamide sulfoxide. The intra- and inter-day precision values for ethionamide and ethionamide sulfoxide met the acceptance as per FDA guidelines. Ethionamide and ethionamide sulfoxide were stable in battery of stability studies, viz. bench-top, autosampler and freeze-thaw cycles. The developed assay was applied to a pharmacokinetic study in humans. © 2011 John Wiley & Sons, Ltd.


A highly sensitive and specific LC-MS/MS method has been developed for simultaneous quantification of ethionamide and ethionamide sulfoxide in human plasma (300L) using prothionamide as an internal standard (IS). Solid-phase extraction was used to extract ethionamide, ethionamide sulfoxide and IS from human plasma. The chromatographic separation of ethionamide, ethionamide sulfoxide and IS was achieved with a mobile phase consisting of 0.1% acetic acid:acetonitrile (20:80, v/v) at a flow rate of 0.50mL/min on a Peerless Basic C(18) column. The total run time was 3.5min and the elution of ethionamide, ethionamide sulfoxide and IS occurred at 2.50, 2.18 and 2.68min, respectively. A linear response function was established for the range of concentrations 25.7-6120ng/mL (r > 0.998) for ethionamide and 50.5-3030ng/mL (r > 0.998) for ethionamide sulfoxide. The intra- and inter-day precision values for ethionamide and ethionamide sulfoxide met the acceptance as per FDA guidelines. Ethionamide and ethionamide sulfoxide were stable in battery of stability studies, viz. bench-top, autosampler and freeze-thaw cycles. The developed assay was applied to a pharmacokinetic study in humans.

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