Development and evaluation of an efficient HPLC/MS/MS method for the simultaneous determination of pseudoephedrine and cetirizine in human plasma: Application to Phase-I pharmacokinetic study

Ma, Ming; Fěng, Fang; Sheng, Yulan; Cui, Shuangjin; Han, Lijun

doi:10.1016/j.jchromb.2006.08.026

Cited by 57 publications

(35 citation statements)

References 14 publications

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“…It has been reported that analysis of plasma samples following administration of an oral tablet formulation composed of 5 mg CTZ and 120 mg PSU to healthy volunteers provided maximum concentrations of 167 ± 47, 350.36 ± 57.33 ng/mL reached within 0.7 ± 0.5, 4 ± 0.8 h and having t 1/2 value of 6.76 ± 1.82 h and 5.37 ± 0.52 for the two drugs, respectively [11]. Another study concerned with the pharmacokinetics of PCA mentioned that 7.56 ± 2.18 μg/mL is the maximum plasma concentration attained within 0.77±0.45 h, and half life time of 2.91±0.45 h [22].…”

Section: Application To Spiked and Real Human Plasmamentioning

confidence: 97%

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Chemometrically optimized micellar liquid chromatographic method for the simultaneous determination of cetirizine dihydrochloride in its combined dosage forms. Application to biological fluids and pharmacokinetic studies

El-Din¹,

Ibrahim²,

Eid³

et al. 2013

Acta Chromatographica

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Abstract. An accurate, simple, sensitive, and selective micellar liquid chromatographic method has been developed for the simultaneous determination of cetirizine dihydrochloride in two of its combined pharmaceutical preparations with psudoephedrine hydrochloride and/or paracetamol. The chemometrics approach was applied for the optimization of separation of the studied drugs to optimize their separation; the effect of six experimental parameters on retention was investigated by means of multivariate analysis. Separation was conducted using an ODS C18 (150 × 4.6 mm id) stainless steel column at ambient temperature with UV-detection at 250 nm. A mobile phase composed of 0.135 M sodium dodecyl sulphate, 11% 1-propanol, 0.3% tri-ethylamine in 0.02 M phosphoric acid, and adjusted to pH 3.3 has been used at a flow rate of 1 mL/min. Regression models were characterized by both descriptive and predictive ability (R 2 ≥ 98.8% and R 2 cv ≥ 94.5%) and allowed the chromatographic separation of the drugs with a good resolution and a total analysis time within 6 min.The calibration curves were rectilinear over the concentration ranges of 0.05-1.0, 0.07-4.0, and 1.0-10.0 μg/mL for cetirizine dihydrochloride, psudoephedrine hydrochloride, and paracetamol respectively; with detection limits of 0.01, 0.05, and 0.08 μg/mL, and quantification limits of 0.04, 0.09, and 1.02 μg/mL, respectively. The results obtained were in good agreement with those obtained by the comparison method. Furthermore, the method was applied for the determination of the drugs in spiked human plasma and used to reveal the pharmacokinetic characters in a healthy volunteer treated with oral administration of the studied two combined dosage forms of cetirizine.

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Section: Application To Spiked and Real Human Plasmamentioning

confidence: 97%

“…Several HPLC methods have been reported in literature for the determination of PCA with CTZ [4,5], PCA with PSU [6][7][8][9], and CTZ with PSU [10][11][12]. The three drugs were also determined in the presence of their degradation products [13].…”

Section: Introductionmentioning

confidence: 99%

Chemometrically optimized micellar liquid chromatographic method for the simultaneous determination of cetirizine dihydrochloride in its combined dosage forms. Application to biological fluids and pharmacokinetic studies

El-Din¹,

Ibrahim²,

Eid³

et al. 2013

Acta Chromatographica

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“…For quality control to analyze the index component of peony, there are currently a number of methods used for the determination of paeoniflorin in medicines and biological samples, including high-performance liquid chromatography (HPLC) [4], ultra-performance liquid chromatographyelectrospray tandem mass spectrometry (UPLC-ESI-MS/ MS) [5], and HPLC/MS/MS [6,7], which display high sensitivity, reliability and validity for use in studies.…”

Section: Introductionmentioning

confidence: 99%

Development of Fluorescence-Linked Immunosorbent Assay for Paeoniflorin

Zhao

Wang

et al. 2015

J Fluoresc

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In this study, we developed a fluorescent immunoassay approach to detect paeoniflorin (PF) using a fluorescently labelled monoclonal antibody. The PF-specific antibody was purified by the caprylic acid-ammonium sulfate method and protein G Sepharose 4 Fast Flow column and then labelled with fluorescein isothiocyanate (FITC). The FITC-labelled monoclonal antibody was highly specific for PF, with less than 0.076 % cross-reactivity to seven structurally related compounds. The FITC-labelled monoclonal antibody was then used to develop an indirect competitive enzyme-linked immunosorbent assay (icELISA) and indirect competitive fluorescence-linked immunosorbent assay (icFLISA), respectively. FLISA is simple, rapid and sensitive, with a 500-fold lower limit of detection (LOD) compared with conventional ELISA. Finally, using a variety of standards, FLISA was validated. We observed a strong correlation between the results determined by either FLISA or conventional HPLC for the quantification of PF levels (R(2) = 0.9927). Collectively, this study shows that the icFLISA method can be successfully applied for the detection and quantification of PF in medicines and biological samples.

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“…LC-MS/MS in particular, is the most popular analytical technique primarily because of its inherent selectivity and sensitivity. [5][6][7][8][9][10][11][12][13][14][15][16][17] The other techniques including capillary electrophoresis, ion-pair LC and ion mobility spectrometry have also been utilized for the determination of pseudoephedrine with other drugs in various biological and pharmaceutical samples. [18][19][20] Evaluations of monolithic columns have shown them to be equivalent to commercially available particle packed columns in terms of high binding capacity, high flow rates with low back pressure leading to fast separations, higher mass transfer kinetics, and increased efficiency.…”

Section: Introductionmentioning

confidence: 99%

Multi-component quantitation of loratadine, pseudoephedrine and paracetamol in plasma and pharmaceutical formulations with liquid chromatography-tandem mass spectrometry utilizing a monolithic column

Abro

Memon²,

Bhanger³

et al. 2012

Quím. Nova

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Recebido em 16/2/12; aceito em 5/7/12; publicado na web em 25/9/12The purpose of this study was to develop a rapid, simple and sensitive quantitation method for pseudoephedrine (PSE), paracetamol (PAR) and loratadine (LOR) in plasma and pharmaceuticals using liquid chromatography-tandem mass spectrometry with a monolithic column. Separation was achieved using a gradient composition of methanol-0.1% formic acid at a flow rate of 1.0 mL min -1. Mass spectral transitions were recorded in SRM mode. System validation was evaluated for precision, specificity and linearity. Limit of detection for pseudoephedrine, paracetamol, and loratadine were determined to be 3.14, 1.86 and 1.44 ng mL -1 , respectively, allowing easy determination in plasma with % recovery of 93.12 to 101.56%.

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Development and evaluation of an efficient HPLC/MS/MS method for the simultaneous determination of pseudoephedrine and cetirizine in human plasma: Application to Phase-I pharmacokinetic study

Cited by 57 publications

References 14 publications

Chemometrically optimized micellar liquid chromatographic method for the simultaneous determination of cetirizine dihydrochloride in its combined dosage forms. Application to biological fluids and pharmacokinetic studies

Chemometrically optimized micellar liquid chromatographic method for the simultaneous determination of cetirizine dihydrochloride in its combined dosage forms. Application to biological fluids and pharmacokinetic studies

Development of Fluorescence-Linked Immunosorbent Assay for Paeoniflorin

Multi-component quantitation of loratadine, pseudoephedrine and paracetamol in plasma and pharmaceutical formulations with liquid chromatography-tandem mass spectrometry utilizing a monolithic column

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