SPE–UPLC–MS/MS method for sensitive and rapid determination of aripiprazole in human plasma to support a bioequivalence study

Patel, Daxesh P.; Sharma, Primal; Sanyal, Mallika; Shrivastav, Pranav S.

doi:10.1016/j.jchromb.2013.02.022

Cited by 26 publications

(19 citation statements)

References 20 publications

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“…amitriptyline) and neutral (e.g. benzodiazepine) drugs and metabolites from biological fluids (Watson et al ., ; Grobosch et al ., ; Gonzalez et al ., ; Patel et al ., ). Extraction conditions of the loading pump were modified for improving the separation of analytes, so 100% of eluent C was initially programmed to increase hydrophilic interaction between analytes and N ‐vinylpyrrolidone ligands of the sorbent (Table , step 1).…”

Section: Resultsmentioning

confidence: 97%

Toxicological screening of human plasma by on‐line SPE‐HPLC‐DAD: identification and quantification of basic drugs and metabolites

Mut

Grobosch

Binscheck-Domaß

et al. 2014

Biomedical Chromatography

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An automated multi-analyte screening method for the identification and quantification of 92 drugs and metabolites based on on-line solid-phase extraction-high-performance liquid chromatography-diode array detection technique was developed and successfully validated. In addition, a database with 870 entries including UV-spectra, relative/retention times and response factors of toxicologically relevant compounds was created. Plasma samples (0.2 mL) were treated with methanol, diluted with buffer and on-line extracted (Strata X, 20 ×2 mm, 25 µm) at pH 9. Analytical separation was carried out on a Gemini NX column (150 ×4.6 mm, 3 µm) using gradient elution with acetonitrile-water (90:10,v/v) and 0.05 m potassium dihydrogen phosphate buffer (pH 2.3). Linear calibration curves with correlation coefficients ≥0.9950 were obtained for 78 analytes. As an additional benefit, the newly developed method allows the quantification of 42 analytes (e.g. antidepressants, neuroleptics and anticonvulsants) in a concentration range suitable for therapeutic drug monitoring. Limits of quantitation ranged from 0.02 mg/L (chlordiazepoxide) to 3.4 mg/L (mexiletine). Inter- and intra-day precisions of quality control samples (low/high) were better than 15% (zolpidem) and accuracy (bias) ranged from -11% (opipramol, venlafaxine) to 11% (venlafaxine, trazodone). Tests for carry-over and sample stability under different storage conditions were also performed and stability was adequate. Four cases of poisoning analysis are presented.

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Section: Resultsmentioning

confidence: 97%

Toxicological screening of human plasma by on‐line SPE‐HPLC‐DAD: identification and quantification of basic drugs and metabolites

Mut

Grobosch

Binscheck-Domaß

et al. 2014

Biomedical Chromatography

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“…An overview of SPE applications for selected antidepressants and antipsychotics is given in Supplementary Table 1. Six methods applied SPE to plasma 36,38,40,41,51,55,58 , one method to serum 59 , one to brain tissue 61 and one to human urine 49 . Different retention mechanisms have been applied.…”

Section: Solid Phase Extractionmentioning

confidence: 99%

“…Regardless of the used material, the number of monitored analytes influences the demands for the sample preparation method. Most of the published methods have focused on the analysis of one [28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44] or less than seven compounds [45][46][47][48][49][50][51][52][53][54] . For certain applications, psychotropic drugs are analysed in combination with other pharmaceuticals 55,56 .…”

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confidence: 99%

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Quantification of selected antidepressants and antipsychotics in clinical samples using chromatographic methods combined with mass spectrometry: A review (2006-2015)

Sistik¹,

Turjap²,

Iordache³

et al. 2016

Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub

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This review describes major advances and drawbacks in the field of chromatography coupled with single or tandem mass spectrometry (LC-MS, LC-MS/MS and GC/MS) of selected antidepressants (agomelatine, vilazodone) and antipsychotics (iloperidone, asenapine, amisulpride, aripiprazole, melperone, zotepine, ziprasidone). The high specificity in combination with high sensitivity makes these techniques an attractive complementary method to traditional procedures used in routine practice for TDM.

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“…1. A few method have been reported as single analyte or in combination with other drugs in spectrophotometric studies [3][4][5][6][7] and biological samples include liquid chromatography (LC) [8][9][10][11][12], gas chromatography-mass spectrometry (MS) [13], LC-MS/MS [14][15][16][17][18], capillary electrophoresis [19,20], and LC-ultraviolet (UV) [16] methods. This study was aimed to develop a simple, accurate, precise and robust validated stability indicating costeffective method using reverse phase high performance LC (HPLC) and was extended for its formulations and bulk samples than existing one.…”

Section: Introductionmentioning

confidence: 99%

A Novel Stability Indicating Rp-HPLC Method Development and Validation for the Quantification of Aripiprazole in Pure and Its Pharmaceutical Formulation

Ayaan

Vijayabharathi

2017

Asian J Pharm Clin Res

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Objective: This study was aimed to develop a novel, selective, and sensitive reverse phase high performance liquid chromatography method for the detection and quantification of aripiprazole in pure form as well as in its pharmaceutical formulation.Methods: The chromatography was carried out on C18 Phenomenex Luna (250 × 4.6 mm × 5 μm) column using a mobile phase of 0.1% v/v orthophosphoric acid (pH 3.0), acetonitrile and methanol in the ratio of 40:50:10 (% v/v). The isocratic elution program was adjusted to 1.0 ml/minutes flow rate with 20 μl injection volume. The eluted components were monitored at 254 nm. The ambient column oven temperature was maintained.Results: The developed method was validated statistically with respect to linearity, range, precision, accuracy, specificity, robustness, ruggedness, detection and quantification limits and also subjected to various stress conditions such as acidic and alkaline hydrolysis, oxidation, photolysis, and thermal degradation. The method showed linearity across the concentration range of 10.0-60 μg/ml.Conclusion: The developed method is specific, precise, accurate, robust and stability indicating which can be successfully applied for routine analysis, quality control analysis and also suitable for stability analysis of assay of aripiprazole in pure form and its formulation as per the regulatory requirements.Keywords: Aripiprazole, Reverse phase high performance liquid chromatography, Stress condition.

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SPE–UPLC–MS/MS method for sensitive and rapid determination of aripiprazole in human plasma to support a bioequivalence study

Cited by 26 publications

References 20 publications

Toxicological screening of human plasma by on‐line SPE‐HPLC‐DAD: identification and quantification of basic drugs and metabolites

Toxicological screening of human plasma by on‐line SPE‐HPLC‐DAD: identification and quantification of basic drugs and metabolites

Quantification of selected antidepressants and antipsychotics in clinical samples using chromatographic methods combined with mass spectrometry: A review (2006-2015)

A Novel Stability Indicating Rp-HPLC Method Development and Validation for the Quantification of Aripiprazole in Pure and Its Pharmaceutical Formulation

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