Analysis of the anti-Parkinson drug pramipexole in human urine by capillary electrophoresis with laser-induced fluorescence detection

Musenga, Alessandro; Kenndler, Ernst; Morganti, Emanuele; Rasi, F; Raggi, Maria Augusta

doi:10.1016/j.aca.2008.07.035

Cited by 27 publications

(16 citation statements)

References 18 publications

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“…Several studies have been published for the determination of achiral PAL in biological samples by CE coupled with laser-induced fluorescence detection [26] or liquid chromatography (LC) with electrochemical and UV detection [27] or with atmospheric pressure chemical ionization tandem mass spectrometry [28]. Recently, an experimental design LC analysis of PAL and its impurities was also performed [29].…”

Section: Introductionmentioning

confidence: 99%

Development and validation of a chiral capillary electrophoresis method for assay and enantiomeric purity control of pramipexole

Deng

Hai

Vervoort

et al. 2011

J of Separation Science

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A rapid method for the enantioseparation of pramipexole and its R-enantiomer has been developed by capillary electrophoresis. The influence of chemical and instrumental parameters was investigated including the type and concentration of chiral selectors, buffer composition and pH, co-ions, applied voltage, capillary length and temperature. Optimal separation conditions were obtained using a 50 mM phosphate buffer (pH 2.8) containing 25 mM carboxymethyl-β-cyclodextrin on a fused-silica capillary. Online UV detection was performed at 262 nm. A voltage of 25 kV was applied, and the capillary temperature was kept at 25°C. Hydrodynamic injection was performed at 3.45 kPa for 5.0 s. The separation of enantiomers was achieved in <6.5 min. The method was further validated in terms of stability of solutions, selectivity, linearity (both pramipexole and R-enantiomer, R(2) >0.995), LOD and LOQ (0.91 and 2.94 μg/mL, respectively), repeatability (RSD<1.5%) and accuracy (pramipexole, 100.4%; R-enantiomer, 100.5%). The proposed method was then applied to two kinds of pramipexole dihydrochloride monohydrate commercially available tablets, immediate release tablets (1.50 and 0.125 mg) and sustained release tablets (0.52 mg), to quantify the main component in the tablets. The amount of distomer could be quantified in bulk sample materials.

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Section: Introductionmentioning

confidence: 99%

Development and validation of a chiral capillary electrophoresis method for assay and enantiomeric purity control of pramipexole

Deng

Hai

Vervoort

et al. 2011

J of Separation Science

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“…We related the better resolution to the combined effects of the ionic strength [22] and the interaction of the analyte with the additive [21], but the reduction of the EOF played a role as well. Using a pH 10.3 borate buffer, low concentrations (5% and 10%) of organic solvents (methanol and acetonitrile) in the BGE led to an expected increase in the migration times of the sample constituents, but no improvement was obtained in terms of separation.…”

Section: Choice Of the Bgementioning

confidence: 94%

“…In our previous works [21,22,24] we observed that the addition of amines, organic solvents or cyclodextrins (or a suitable combination of these additives) can improve the separation. We related the better resolution to the combined effects of the ionic strength [22] and the interaction of the analyte with the additive [21], but the reduction of the EOF played a role as well.…”

Section: Choice Of the Bgementioning

confidence: 97%

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Determination of duloxetine in human plasma by capillary electrophoresis with laser-induced fluorescence detection

Musenga

Amore

Mandrioli

et al. 2009

Journal of Chromatography B

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“…Those methods are based on spectrophotometry (Armağan, 2011;Babu, Raju, 2007;El-Bayoumi, 2009;Gurupadayya, Vishwajith, Srujana, 2009;Rani, Reddy, 2006;Rani, Reddy, 2007;Thangabalan et al, 2011a,b), high-performance liquid chromatography (HPLC) (El-Sherif, Abdel-Fattah, El-Houssini, 2008;Hua et al, 2011;Jancic et al, 2007a,b;Kamienska-Duda, Kosmacinska, 2008;Malenovic et al, 2010;Manish et al, 2010;Ramakrishna et al, 2007;Rao et al, 2009;Shuhui, 2010;Srinubabu et al, 2006;Syeda et al, 2010;Vijaya et al, 2009), gas chromatography (Panchal, Patel, Menon, 2011), and capillary electrophoresis (Musenga et al, 2008;Chang-Hai et al, 2009).…”

Section: Introductionmentioning

confidence: 99%

Validation of high performance liquid chromatographic and spectrophotometric methods for the determination of the antiparkinson agent pramipexole dihydrochloride monohydrate in pharmaceutical products

Sevim

Erk

2015

Braz. J. Pharm. Sci.

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The antiparkinson agent pramipexole dihydrochloride monohydrate was quantified in pharmaceutical products by high performance liquid chromatography (HPLC) and derivative spectrophotometry. The first method was based on HPLC using tamsulosin HCl as an internal standard. In this method, chromatographic separation was achieved using a LiChrospher 60 RP column at 25°C, with a flow rate of 1.0 mL/min at 263 nm. The eluent comprised 0.01 mol/L ammonium acetate (pH 4.4) and acetonitrile (35:65 by volume). The linearity range was found to be 10.0-30.0 µg/mL with a mean recovery of 100.5 ± 1.10. The limit of detection (8 ng/mL) and limit of quantification (50 ng/mL) were calculated. In the second method, the first derivative spectrophotometric technique for the determination of pramipexole dihydrochloride monohydrate was performed by measuring the amplitude at 249 and 280 nm. In the first derivative technique, the absorbance and concentration plot was rectilinear over the 5.0-35.0 µg/mL range with a lower detection limit of 1.5 ng/mL and quantification limit of 4.5 ng/mL. The typical excipients included in the pharmaceutical product do not interfere with the selectivity of either method. The developed methods were validated for robustness, selectivity, specificity, linearity, precision, and accuracy as per the ICH and FDA guidelines (ICH Q2B, 1996; FDA,2000). In conclusion, the developed methods were successful in determining the quantity of the antiparkinson agent pramipexole dihydrochloride monohydrate in pharmaceutical products. The RSD values for the pharmaceutical product used in this study were found to be 0.97% for the HPLC method and 0.00% for the first derivative spectrophotometric method. O fármaco antiparkinsoniano, dicloridrato de pramipexol monoidratado, foi quantificado no produto farmacêutico por cromatografia líquida de alta eficiência (CLAE) e espectrofotometria derivada. No primeiro método baseado na CLAE, o cloridrato de tansulosina foi usado como padrão interno. Nesse método, a separação cromatográfica foi realizada usando uma coluna Lichrosper 60 RP a 25 °C e acetato de amônio 0,01 mol/L (pH:4.4): acetonitrila (35:65 em volume) como eluente com fluxo de 1,0 mL /min a 263 nm. A faixa de linearidade foi de 10.0-30.0 µg/mL com média da recuperação 100.5 ± 1.10. O limite de detecção (8 ng/mL) e o limite de quantificação (50 ng/mL) foram calculados. Por outro lado, a primeira técnica de espectrofotometria derivada para a determinação de dicloridrato de pramipexol monoidratado foi realizada através da medida da amplitude a 249 e 280 nm. Na técnia da primeira derivada, a absorvância e a plotagem da concentração foi retilínea na faixa de 5.0-35.0 µg/mL com limite inferior de detecção de 1.5 ng/mL e limite de quantificação de 4.5 ng/mL. Os excipientes típicos incluídos no produto farmacêutico não interferem com a seletividade dos métodos. Os métodos desenvolvidos foram validados quanto à robustez, seletividade, especificidade, linearidade, precisão e S. Sevim, N. Erk 880 exatidão de acordo com as diretrizes d...

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Analysis of the anti-Parkinson drug pramipexole in human urine by capillary electrophoresis with laser-induced fluorescence detection

Cited by 27 publications

References 18 publications

Development and validation of a chiral capillary electrophoresis method for assay and enantiomeric purity control of pramipexole

Development and validation of a chiral capillary electrophoresis method for assay and enantiomeric purity control of pramipexole

Determination of duloxetine in human plasma by capillary electrophoresis with laser-induced fluorescence detection

Validation of high performance liquid chromatographic and spectrophotometric methods for the determination of the antiparkinson agent pramipexole dihydrochloride monohydrate in pharmaceutical products

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