Thu, 19 Apr 2018

Bioanalysis of mosapride by a novel LC–MS/MS method by using solid phase extraction technique: a pharmacokinetic application in Indian subjects

Gopi Kalyan Kumar Boligarla 1*, Veldandi Saritha 2, L. Reddy Gantla 3, P. Venkata Ramana4, T. Raveendranath Babu 5, Sreedhar NY 1

1.Electroanalytical Lab, Department of Chemistry, Sri Venkateswara University, Tirupati–517 502,  India

2.Department of Pharmacy, Palamuru University, Mahaboobnagar–509 001, India

3.Department of Statistics, University College of Sciences, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur-522 510, India.

4.Department of Chemistry, University College of Sciences, Sri Krishnadevaraya University, Anantapur-515 003, India.

5.Department of Chemistry, N.B.K.R. Science and Arts College, Vidyanagar,
Kota mandal, Nellore-A.P.,524 413, India.


ABSTRACT

In this paper the authors proposed a simple, sensitive and selective liquid chromatography–tandem mass spectrometry (LC–MS/MS) assay method for the determination of mosapride in human plasma. This method employed mosapride–d5 as an internal standard (IS). Analyte and the IS were extracted form 100 µL of human plasma using solid–phase extraction with no drying, evaporation and reconstitution steps. The chromatographic separation was achieved on a C18 column by using a mixture of methanol and 5mM ammonium acetate (80:20, v/v) as the mobile phase at a flow rate of 1.0 mL/min. The linearity of the method was established in the concentration range 0.18–60.0 ng/mL with r2 ³ 0.99. The intra–day and inter–day precision (%CV) and accuracy results in five validation batches across five concentration levels were well within the acceptance limits. The validated method was found to be applicable to clinical studies.

Keywords: Mosapride, Human plasma, Solid–phase extraction (SPE), LC–MS/MS, Pharmacokinetics


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