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LC-MS/MS Assay for Quantification of a Novel Antidiabetic Flavone Derivative S002-857 in Rat Plasma, Urine and Feces: Application in Pharmacokinetic Studies

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Abstract

This study aimed to develop an LC-MS/MS assay for the quantitation of S002-857 in plasma, urine and feces to evaluate the pharmacokinetic parameters and elimination pathway for further development of S002-857. A sensitive and selective LC-MS/MS method was developed and validated for estimating a novel antidiabetic flavone derivative, S002-857, synthesized by Central Drug Research Institute, CSIR, Lucknow, India. Plasma and urine samples were prepared by two-step liquid-liquid extraction with diethyl ether and feces by protein precipitation using acetonitrile. The analyte was chromatographed on a cyano column with methanol-ammonium acetate buffer (pH 4.6, 10 mM; 90:10, v/v). The calibration curves were linear over a range of 0.78–400 ng mL−1 for plasma and 1.56–400 ng mL−1 for urine and feces samples. The accuracy and precision were <15% for plasma, urine and feces samples. The recoveries from spiked plasma, urine and feces samples were >85%. S002-857 was stable in plasma for 8 h at ambient temperature, 30 days at −60 °C and after three freeze-thaw cycles. The assay was successfully applied to determine the pharmacokinetic parameters and excretion profile in male rats.

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Acknowledgments

The authors are thankful to the director of CDRI for providing the facilities and infrastructure for the study. The authors also acknowledge to Council of Scientific and Industrial Research (CSIR) and University Grant Commission (UGC), New Delhi, India, for providing research fellowships. (CDRI Communication No. 8027)

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Authors and Affiliations

  1. Pharmacokinetics and Metabolism Division, Central Drug Research Institute, CSIR, Lucknow, 226001, India

    Nagsen Gautam, Hari Narayan Kushwaha, Hemant Kumar & Shio Kumar Singh

  2. Medicinal and Process Chemistry Division, Central Drug Research Institute, CSIR, Lucknow, 226001, India

    Ram Pratap

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  1. Nagsen Gautam
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  2. Hari Narayan Kushwaha
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  3. Hemant Kumar
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  4. Ram Pratap
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  5. Shio Kumar Singh
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Correspondence to Shio Kumar Singh.

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Gautam, N., Kushwaha, H.N., Kumar, H. et al. LC-MS/MS Assay for Quantification of a Novel Antidiabetic Flavone Derivative S002-857 in Rat Plasma, Urine and Feces: Application in Pharmacokinetic Studies. Chromatographia 73, 905–912 (2011). https://doi.org/10.1007/s10337-011-1978-6

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  • DOI: https://doi.org/10.1007/s10337-011-1978-6

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