Determination of ziprasidone in human plasma by liquid chromatography–electrospray tandem mass spectrometry and its application to plasma level determination in schizophrenia patients

Aravagiri, Manickam; Marder, Stephen R.; Pollock, Bruce G.

doi:10.1016/j.jchromb.2006.10.024

Cited by 25 publications

(20 citation statements)

References 19 publications

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“…LC-MS methods offer several significant advantages when compared with previous methods, such as the small sample volume required, minimization of mobile phase, rapid analytical run time and improved sensitivity, selectivity and specificity (Srinivas, 2006). To date, only a few LC-MS/ MS methods have been reported for the quantitation of ZIP in plasma (Janiszewski et al, 1997;Al-Dirbashi et al, 2006;Aravagiri et al, 2007). However, these papers did not report the matrix effects for ZIP from plasma when using LC-MS methods.…”

Section: Introductionmentioning

confidence: 99%

Determination of the lipophilic antipsychotic drug ziprasidone in rat plasma and brain tissue using liquid chromatography–tandem mass spectrometry

Zhang

Terry

Bartlett

2008

Biomedical Chromatography

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A simple, sensitive and robust liquid chromatography/electrospray ionization tandem mass spectrometry (LCESI-MS/MS) method with low matrix effects was developed and validated for the quantification of the lipophilic antipsychotic ziprasidone from rat plasma and brain tissue. Ziprasidone was extracted from rat plasma and brain homogenate using a single-step liquid-liquid extraction. Ziprasidone was separated on an Agilent Eclipse XDB C8 column (150 x 2.1 mm i.d., 5 microm) column using a mobile phase of acetonitrile-0.02% ammonia in water (pH 7.20 adjusted with formic acid) using gradient elution. Ziprasidone was detected in the positive ion mode using multiple reaction monitoring. The method was validated and the specificity, linearity, lower limit of quantitation (LLOQ), precision, accuracy, recovery, matrix effects and stability were determined. The LLOQ was 0.2 ng/mL for plasma and 0.833 ng/g for brain tissue. The method was linear over the concentration range from 0.2 to 200.0 ng/mL for plasma and 0.833-833.3 ng/g for brain tissue. The correlation coefficient (R2) values were more than 0.996 for both plasma and brain homogenate. The precision and accuracy intra-day and inter-day were better than 8.13%. The relative and absolute recovery was above 81.0% and matrix effects were lower than 5.2%. This validated method has been successfully used to quantify the rat plasma and brain tissue concentration of ziprasidone after chronic treatment.

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Section: Introductionmentioning

confidence: 99%

Determination of the lipophilic antipsychotic drug ziprasidone in rat plasma and brain tissue using liquid chromatography–tandem mass spectrometry

Zhang

Terry

Bartlett

2008

Biomedical Chromatography

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“…Therefore, it is not surprising that several LLE methods have been reported for them (Sucknow et al, 2004;Al-Dirbashi et al, 2006;Aravagiri et al, 2007;Shimokawa et al, 2005;Kubo et al, 2005). An accurate, rapid and simple LC-MS/MS assay method was developed for the determination of ZIP in the plasma of schizophrenic patients (Aravagiri et al, 2007). A 0.5 mL aliquot of plasma was extracted using a simple one-step LLE with 20% methylene chloride in pentane.…”

Section: Liquid-liquid Extractionmentioning

confidence: 99%

“…The selection of specific analyte ion(s) with the first quadrupole and diagnostic abundant fragment ion(s) with the third quadrupole results in a technique called multiple reaction monitoring. Many sensitive GC-MS, LC-MS or LC-MS/MS methods for bioanalysis of antipsychotics have been published (Niederländer et al, 2006;Zhang et al, 2007a,b,d;Janiszewski et al, 1997;Al-Dirbashi et al, 2006;Aravagiri and Marder, 2000;Aravagiri et al, 2007;Lin et al, 2004;Barrett et al, 2007;Kubo et al, 2005;Josefsson et al, 2003;Kollroser and Schober, 2002;Zhou et al, 2004;Kirchherr and Kuhn-Velten, 2006;Li et al, 2007;Remmerie et al, 2003;Bhatt et al, 2006;Flarakos et al, 2004;Berna et al, 1998Berna et al, , 2002Bogusz et al, 1999;Gervasini et al, 2003;Nirogi et al, 2006;Hattori et al, 1986;Arinobu et al, 2002;McKay et al, 1982). Zhang et al (2005) described a LC-MS method for the quantitation of RISP and 9-OH RISP in human plasma.…”

Section: Mass Spectrometersmentioning

confidence: 99%

Bioanalytical methods for the determination of antipsychotic drugs

Zhang

Terry

Bartlett

2008

Biomedical Chromatography

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Antipsychotic drugs are popular for the treatment of schizophrenia and other psychoses. In general, antipsychotics are administered in oral doses of only a few milligrams per day and they are widely metabolized in the body. Therefore, the concentration of these drugs in plasma is very low (pg-ng/mL levels). In addition, therapeutic drug monitoring (TDM) of antipsychotic drugs has proven to be of notable value for determining poor compliance of patients and addressing the challenges associated with considerable genetic variability in their metabolism. Thus, in order to conduct pharmacology and toxicology studies and clinical TDM of antipsychotics, as well as address the challenges associated with polypharmacy and drug metabolism, highly sensitive, selective and accurate bioanalytical methods are essential. The most recent studies on the determination of antipsychotics will be reviewed, including separation techniques, sample pretreatment, detectors and validation.

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“…[1,2] Ziprasidone is most effective in schizophrenia, a chronic illness that requires lifelong treatment spread over approximately 1% of the world's population. [3,4] Literature survey for ziprasidone revealed several analytical methods based on different techniques, viz, LC-MS [5][6][7] assay for their quantification in plasma and brain, high performance liquid chromatography (HPLC) [8][9][10] method for simultaneous determination of ziprasidone in capsule formulation, and HPLC-UV [11] methods for determination ziprasidone in human plasma and urine, LC [12] with fluorescence for determination of plasma ziprasidone, and capillary zone electrophoresis [13] for determination of ziprasidone in pharmaceutical formulations.…”

Section: Introductionmentioning

confidence: 99%

Development and validation of stability indicating UPLC assay method for ziprasidone active pharma ingredient

Mittal¹,

Gupta

Narasimhan

et al. 2012

Chron Young Sci

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Aim: The analytical method has been developed to evaluate the efficacy of the cleaning procedure of all the equipment involved in the production of final active ingredients. The choice of the methodology is based on the production method and on the intrinsic properties of the products. For this validation, high-performance liquid chromatography (HPLC) method has been chosen. Materials and Methods: The HPLC chromatographic separations were achieved on (100 mm × 4.6 mm), 3.5 µm make: Phenomenex column employing acetonitrile and 0.5% orthophosphoric acid aqueous solution in the ratio of 35:65 as mobile phase with flow rate 1.0 mL/min was chosen. The column temperature was maintained at 30°C, and a detector wavelength of 230 nm was employed. Results and Discussion: The method was successfully validated by establishing system suitability, specificity, linearity, accuracy, limit of detection (LOD), and limit of quantification (LOQ) as per ICH guidelines. Conclusion: The method was completely validated showing satisfactory data for all methods-validated parameters tested. Satisfactory validation parameters such as linearity, recovery, precision, LOD, and LOQ were established by following ICH guidelines. Therefore, the proposed analytical procedure could be useful for regular monitoring, pharma manufacturing laboratories, and researchers.

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Determination of ziprasidone in human plasma by liquid chromatography–electrospray tandem mass spectrometry and its application to plasma level determination in schizophrenia patients

Cited by 25 publications

References 19 publications

Determination of the lipophilic antipsychotic drug ziprasidone in rat plasma and brain tissue using liquid chromatography–tandem mass spectrometry

Determination of the lipophilic antipsychotic drug ziprasidone in rat plasma and brain tissue using liquid chromatography–tandem mass spectrometry

Bioanalytical methods for the determination of antipsychotic drugs

Development and validation of stability indicating UPLC assay method for ziprasidone active pharma ingredient

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