Simultaneous Determination of Atorvastatin and Aspirin in Human Plasma by LC–MS/MS: Its Pharmacokinetic Application

GAJULA, Ramakrishna; PILLI, Nageswara Rao; RAVI, Vasu Babu; MADDELA, Rambabu; INAMADUGU, Jaswanth Kumar; POLAGANI, Srinivasa Rao; BUSA, Sobha

doi:10.3797/scipharm.1206-12

Open AccessArticle

Simultaneous Determination of Atorvastatin and Aspirin in Human Plasma by LC–MS/MS: Its Pharmacokinetic Application

by

Ramakrishna GAJULA

,

Nageswara Rao PILLI

^*,

Vasu Babu RAVI

,

Rambabu MADDELA

,

Jaswanth Kumar INAMADUGU

,

Srinivasa Rao POLAGANI

and

Sobha BUSA

Wellquest Clinical Research, Mirrakamshetty Mall, Ramanthapur, Hyderabad 500013, India

^*

Author to whom correspondence should be addressed.

Sci. Pharm. 2012, 80(4), 923-940; https://doi.org/10.3797/scipharm.1206-12

Submission received: 23 June 2012 / Accepted: 6 August 2012 / Published: 6 August 2012

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Abstract

A simple, rapid, and sensitive liquid chromatography tandem mass spectro-metric (LC–MS/MS) assay method has been developed and fully validated for the simultaneous quantification of atorvastatin and aspirin in human plasma using a polarity switch. Proguanil and furosemide were used as the internal standards for the quantification of atorvastatin and aspirin, respectively. The analytes were extracted from human plasma by the liquid–liquid extraction technique using methyl tert-butyl ether. The reconstituted samples were chromatographed on a Zorbax XDB Phenyl column by using a mixture of 0.2% acetic acid buffer, methanol, and acetonitrile (20:16:64, v/v) as the mobile phase at a flow rate of 0.8 mL/min. Prior to detection, atorvastatin and aspirin were ionized using an ESI source in the multiple reaction monitoring (MRM) mode. The ions were monitored at the positive m/z 559.2→440.0 transition for atorvastatin and the negative m/z 179.0→136.6 transition for aspirin. The calibration curve obtained was linear (r² ≥ 0.99) over the concentration range of 0.20–151 ng/mL for atorvastatin and 15.0–3000 ng/mL for aspirin. The method validation was performed as per FDA guidelines and the results met the acceptance criteria. A run time of 3.0 min for each sample made it possible to analyze more than 300 human plasma samples per day. The proposed method was found to be applicable to clinical studies.

Keywords: Atorvastatin; Aspirin; Acetylsalicylic acid; Liquid–liquid extraction; Chromatography; Pharmacokinetics

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MDPI and ACS Style

GAJULA, R.; PILLI, N.R.; RAVI, V.B.; MADDELA, R.; INAMADUGU, J.K.; POLAGANI, S.R.; BUSA, S. Simultaneous Determination of Atorvastatin and Aspirin in Human Plasma by LC–MS/MS: Its Pharmacokinetic Application. Sci. Pharm. 2012, 80, 923-940. https://doi.org/10.3797/scipharm.1206-12

AMA Style

GAJULA R, PILLI NR, RAVI VB, MADDELA R, INAMADUGU JK, POLAGANI SR, BUSA S. Simultaneous Determination of Atorvastatin and Aspirin in Human Plasma by LC–MS/MS: Its Pharmacokinetic Application. Scientia Pharmaceutica. 2012; 80(4):923-940. https://doi.org/10.3797/scipharm.1206-12

Chicago/Turabian Style

GAJULA, Ramakrishna, Nageswara Rao PILLI, Vasu Babu RAVI, Rambabu MADDELA, Jaswanth Kumar INAMADUGU, Srinivasa Rao POLAGANI, and Sobha BUSA. 2012. "Simultaneous Determination of Atorvastatin and Aspirin in Human Plasma by LC–MS/MS: Its Pharmacokinetic Application" Scientia Pharmaceutica 80, no. 4: 923-940. https://doi.org/10.3797/scipharm.1206-12

APA Style

GAJULA, R., PILLI, N. R., RAVI, V. B., MADDELA, R., INAMADUGU, J. K., POLAGANI, S. R., & BUSA, S. (2012). Simultaneous Determination of Atorvastatin and Aspirin in Human Plasma by LC–MS/MS: Its Pharmacokinetic Application. Scientia Pharmaceutica, 80(4), 923-940. https://doi.org/10.3797/scipharm.1206-12

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Simultaneous Determination of Atorvastatin and Aspirin in Human Plasma by LC–MS/MS: Its Pharmacokinetic Application

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