Simple, rapid RP-HPLC method for estimation of sitagliptin from urine and its application in pharmacokinetics.

Author(s): Vandana Gawande*, Shankar Narvekar, Piyush Rathor, Anil Kumar Singh, Akshada Ajgaonkar, Siddhesh Bamburdekar

Abstract

RP-HPLC method was developed and validated for the estimation of Sitagliptin from urine. The chromatographic separation was carried out on a reverse phase Enable C18 column (250 × 4.6mm, 5μ). A mixture of Potassium dihydrogen phosphate solution (10mM, pH 3) and acetonitrile (70:30 v/v) was used as mobile phase, pumped at 1.0 ml/min and the detection was carried out at 267 nm. Sitagliptin eluted at 6.3 min and analysis can be completed within 8minutes. The method was validated according to USFDA guidelines and found to be linear in the range of 1-150µg/ml. The obtained results indicate that method is linear, precise and accurate. The developed method was used for estimation of sitagliptin in real biological samples and pharmacokinetic studies were done.

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