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Sci. Pharm. 2011, 79(3), 583-600; doi:10.3797/scipharm.1105-12

Development and Validation of Amisulpride in Human Plasma by HPLC Coupled with Tandem Mass Spectrometry and its Application to a Pharmacokinetic Study

1
Jawaharlal Nehru Technological University, Anantapur, Andhra Pradesh515002, India
2
Siddhartha Institute of Pharmaceutical Sciences, Jonnalagadda, Narasaraopet, Guntur, Andhra Pradesh, 522601, India
3
Nirmala College of Pharmacy, Madras Road, Kadapa, Andhra Pradesh, 516002, India
4
Donbosco PG College of Pharmacy, Guntur, Andhra Pradesh, India
§
These authors contributed equally to this work.
*
Author to whom correspondence should be addressed.
Received: 17 May 2011 / Accepted: 25 July 2011 / Published: 25 July 2011
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Abstract

In this study, authors developed a simple, sensitive and specific liquid chromatography–tandem mass spectrometry (LC–MS/MS) method for quantification of Amisulpride in human plasma using Amisulpride-d5 as an internal standard (IS). Chromatographic separation was performed on Zorbax Bonus-RP C18, 4.6 x 75 mm, 3.5 μm column with an isocratic mobile phase composed of 0.2% formic acid:methanol (35:65 v/v), at a flow-rate of 0.5 mL/min. Amisulpride, Amisulpride-d5 was detected at m/z 370.1→242.1 and 375.1→242.1. The drug and the IS were extracted by a liquid-liquid extraction method. The method was validated over a linear concentration range of 2.0–2500.0 ng/mL for Amisulpride with a correlation coefficient of (r2) ≥ 0.9982. This method demonstrated intra- and inter-day precision within 0.9 to 1.7 and 1.5 to 2.8 % and intra- and inter-day accuracy within 98.3 to 101.5 and 96.0 to 101.0 % for Amisulpride. Amisulpride was found to be stable at 3 freeze–thaw cycles, bench top and auto sampler stability studies. The developed method was successfully applied to a pharmacokinetic study.
Keywords: Liquid chromatography–tandam mass spectrometry; Method development; Method Validation; Amisulpride Liquid chromatography–tandam mass spectrometry; Method development; Method Validation; Amisulpride
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

MOGILI, R.; KANALA, K.; CHALLA, B.R.; CHANDU, B.R.; BANNOTH, C.K. Development and Validation of Amisulpride in Human Plasma by HPLC Coupled with Tandem Mass Spectrometry and its Application to a Pharmacokinetic Study. Sci. Pharm. 2011, 79, 583-600.

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