Development and validation of a liquid chromatographic-tandem mass spectrometric method for determination of piperaquine in plasma

Annerberg, Anna; White, Nicholas J.; Day, Nicholas P. J.

doi:10.1016/j.jchromb.2007.12.011

Cited by 146 publications

(106 citation statements)

References 23 publications

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“…Otherwise, it was found that using an isotopelabeled internal standard could also lead to an underestimation of the true concentration. 20 Therefore, it is necessary to find a simple and stable method to reduce any matrix effects. ESI and APCI sources have been widely used as ionization sources in HPLC-MS/MS methods.…”

Section: Resultsmentioning

confidence: 99%

Quantitative Detection of Ambroxol in Human Plasma Using HPLC-APCI-MS/MS: Application to a Pharmacokinetic Study

et al. 2017

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In this study, a rapid and reliable high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method for the determination of ambroxol in human plasma was developed and validated using palmatine as an internal standard (IS). Ambroxol and IS were extracted from 200 μL of human plasma via a simple protein precipitation preparation. Chromatographic separation was achieved on a Platisil C18 column (150 × 4.6 mm, 5 μm) using methanol-0.01% formic acid (70:30, v/v) as the mobile phase at a flow rate of 0.6 mL/min under an isocratic condition. The MS acquisition m/z 379 → 264 for ambroxol and 352 → 336 for IS was performed by atmospheric-pressure chemical ionization (APCI) mass spectrometry in selected reaction monitoring mode. The calibration curve for ambroxol was linear over the concentration range of 2.500 -180.0 ng/mL. The matrix effects of ambroxol ranged from 104.6 to 112.7%. This fully validated method was successfully applied to a pharmacokinetic study of ambroxol in humans after oral administration of ambroxol at a single dose of 75 mg.

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Section: Resultsmentioning

confidence: 99%

Quantitative Detection of Ambroxol in Human Plasma Using HPLC-APCI-MS/MS: Application to a Pharmacokinetic Study

et al. 2017

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“…Literature survey reveals Automated Solid Phase Extraction and Liquid Chromatographic Method 3 , Capillary Zone Electrophoresis 4 , HPLC 5 and LC/MS/MS [6][7][8][9][10][11][12] methods for the estimation of Piperaquine phosphate alone or in combination with other drugs in pharmaceutical formulation and biological samples where as headspace gas chromatographic 13 methods for the estimation of Arterolane maleate alone in pharmaceutical formulation and biological samples. There are very few reported methods for the simultaneous determination of Arterolane maleate and Piperaquine phosphate by RP-HPLC in pharmaceutical dosage forms 14,15 .…”

Section: Fig 2: Structure Of Piperaquine Phosphatementioning

confidence: 99%

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2014

IJPSR

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ABSTRACT:A novel, precise, accurate, rapid and cost effective isocratic reverse-phase high performance liquid chromatographic (RP-HPLC) method was developed, optimized and validated for the estimation of Arterolane maleate and Piperaquine phosphate in pharmaceutical dosage forms (tablet). The drugs were estimated using hypersil C18 (250 mm x 4.6 mm i.d-5 µm particle size) column. A mobile phase composed of phosphate buffer, acetonitrile, methanol in proportion of 40:30:30 v/v, at a flow rate of 1.0 ml/min was used for the separation. Detection was carried out at 244 nm. The linearity range obtained was 20-70 µg/ml for ART and 100-350 µg/ml for PIP with retention times ( R t) of 3.353 min and 2.389 min for ART and PIP respectively. The correlation coefficient values were found to be 0.999. Precession studies showed % RSD values less than 2 % for both the drugs in all the selected concentrations. The percentage recoveries of ART and PIP were in the range of 99.47-100.72% and 99.30-100.18% respectively. The assay results of ART and PIP were 99.57% and 99.75 % respectively. The limit of detection (LOD) and limit of quantification (LOQ) were 0.172 µg/ml 0.524 µg/ml for ART and 0.542 µg/ml and 1.641 µg/ml for PIP respectively. The method was validated as per the International Conference on Harmonization (ICH) guidelines. The proposed validated method was successfully used for the quantitative analysis of commercially available dosage form.

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“…In contrast to GC-MS, substantial isotope effects in the ionization efficacy can be observed with LC-MS/MS. This disadvantage of LC-MS/MS has been demonstrated via observed differences in the quantification of carvedilol (29 ) and piperaquine in plasma (30 ). In the first case, the internal standard did not completely coelute with the analyte, which led to major differences in the ion suppression effects during the analysis of some specimens.…”

Section: Role Of Internal-standard Compoundsmentioning

confidence: 99%

Pitfalls Associated with the Use of Liquid Chromatography–Tandem Mass Spectrometry in the Clinical Laboratory

2010

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BACKGROUND Novel mass spectrometric techniques such as atmospheric pressure ionization and tandem mass spectrometry have substantially extended the spectrum of clinical chemistry methods during the past decade. In particular, liquid chromatography tandem–mass spectrometry (LC-MS/MS) has become a standard tool in research laboratories as well as in many clinical laboratories. Although LC-MS/MS has features that suggest it has a very high analytical accuracy, potential sources of inaccuracy have recently been identified. CONTENT The sources of inaccuracy in LC-MS/MS methods used in the routine quantification of small molecules are described and discussed. Inaccuracy of LC-MS/MS methods can be related to the process of ionization through the insource transformation of conjugate metabolites or target analytes and may also be attributable to ionization matrix effects that have a differential impact on target analytes and internal-standard compounds. Inaccuracy can also be associated with the process of ion selection, which mainly occurs when compounds from the sample matrix share mass transitions with a target analyte. In individual assays, most potential sources of inaccuracy can be controlled by sufficient LC separation–based sample workup before MS analysis. SUMMARY LC-MS/MS methods should undergo rigorous and systematic validation before introduction into patient care.

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Development and validation of a liquid chromatographic-tandem mass spectrometric method for determination of piperaquine in plasma

Cited by 146 publications

References 23 publications

Quantitative Detection of Ambroxol in Human Plasma Using HPLC-APCI-MS/MS: Application to a Pharmacokinetic Study

Quantitative Detection of Ambroxol in Human Plasma Using HPLC-APCI-MS/MS: Application to a Pharmacokinetic Study

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Pitfalls Associated with the Use of Liquid Chromatography–Tandem Mass Spectrometry in the Clinical Laboratory

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