Quantification of pramipexole in human plasma by liquid chromatography tandem mass spectrometry using tamsulosin as internal standard

Nirogi, Ramakrishna; Kandikere, Vishwottam; Shrivastava, Wishu; Mudigonda, Koteshwara; Maurya, Sudarshan; Ajjala, Devender Reddy

doi:10.1002/bmc.864

Cited by 27 publications

(24 citation statements)

References 11 publications

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“…Similarly, for IS the m/z 180.20 precursor ion to the m/z 107.30 was used for quantification purpose. As the earlier publications (Lau et al, 1996;Nirogi et al, 2007) have discussed extensively the fragmentation pattern of PPX, we are not presenting the data pertaining to this.…”

Section: Methods Development Liquid Chromatography and Mass Spectroscopymentioning

confidence: 83%

“…Only two LC-MS/MS methods (Lau et al, 1996;Nirogi et al, 2007) have been reported for quantification of PPX in human plasma. The first LC-MS/MS method, reported by Lau et al (1996), has several disadvantages, viz.…”

Section: Introductionmentioning

confidence: 98%

“…The run time and LLOQ of this method were 3.5 min and 50 pg/mL, respectively (Lau et al, 1996). Subsequently, Nirogi et al, (2007) developed an LC-MS/MS using 500 μL plasma volume using a commercially available IS. However, this method's main drawback is higher LLOQ (200 pg/mL) compared with the earlier method reported by Lau et al (1996), and also long run time (3.5 min), when compared with our method.…”

Section: Introductionmentioning

confidence: 99%

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Development and validation of a sensitive LC‐MS/MS method with electrospray ionization for quantitation of pramipexole in human plasma: application to a clinical pharmacokinetic study

Bharathi¹,

Hotha²,

Sagar³

et al. 2008

Biomedical Chromatography

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A highly sensitive and specific LC-MS/MS method has been developed and validated for the estimation of pramipexole (PPX) with 500 microL human plasma using memantine as an internal standard (IS). The API-4000 was operated under multiple-reaction monitoring mode (MRM) using the electrospray ionization technique. Solid-phase extraction was used to extract PPX and IS from human plasma. The resolution of peaks was achieved with 0.01 m ammonium acetate buffer (pH 4.4):acetonitrile (30:70, v/v) on a Discovery CN column. The total chromatographic run time was 3.0 min and the elution of PPX and IS occurred at approximately 2.32 and 2.52, respectively. The MS/MS ion transitions monitored were 212.10 --> 153.10 for PPX and 180.20 --> 107.30 for IS. The method was proved to be accurate and precise at linearity range of 20-3540 pg/mL with a correlation coefficient (r) of > or =0.999. The intra- and inter-day precision and accuracy values found to be within the assay variability limits as per the FDA guidelines. The developed assay method was applied to a pharmacokinetic study in human volunteers following oral administration of 0.25 mg PPX tablet.

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Section: Methods Development Liquid Chromatography and Mass Spectroscopymentioning

confidence: 83%

Section: Introductionmentioning

confidence: 98%

Section: Introductionmentioning

confidence: 99%

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Development and validation of a sensitive LC‐MS/MS method with electrospray ionization for quantitation of pramipexole in human plasma: application to a clinical pharmacokinetic study

Bharathi¹,

Hotha²,

Sagar³

et al. 2008

Biomedical Chromatography

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“…4 A literature survey reveals a liquid chromatography mass spectroscopy (LCMS) method for determination of pramipexole in human plasma. 5 The high performance liquid chromatography (HPLC) method for pramipexole is also reported for determination of the drug in the tablet dosage form. 6 The determination of the dissociation constant for the pramipexole is also done using chromatography techniques.…”

Section: Stability-indicating Hplc Determination Of Pramipexole Dihydmentioning

confidence: 99%

Stability-indicating HPLC determination of pramipexole dihydrochloride in bulk drug and pharmaceutical dosage form

Panditrao¹,

Sarkate²,

Sangshetti³

et al. 2011

J. Braz. Chem. Soc.

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Um novo método de cromatografia líquida de alta eficiência, indicativo de estabilidade foi desenvolvido e validado para determinação quantitativa de dicloridrato de pramipexol em medicamentos a granel e em doses farmacêuticas na presença de produtos de degradação. Um método de HPLC em fase reversa isocrática foi desenvolvido para separar a droga dos produtos de degradação, usando-se previamente uma coluna cromatográfica Ace5-C18 (250×4,6 mm, 5 µm) e 10 mmol L -1 de acetato de amônia e acetonitrila (75:25 v/v) como fase móvel. A detecção ocorreu num comprimento de onda de 260 nm. O pramipexol foi submetido a condições extremas de hidrólise (ácidos, bases), oxidação, fotólise e degradação térmica. Foi observada degradação para pramipexol em base, em ácido e em 30% H 2 O 2 . Em outras condições extremas, a droga mostrou-se estável. Os produtos de degradação foram bem resolvidos a partir do pico principal. A porcentagem de recuperação do pramipexol foi de 99,87 a 99,98% em doses farmacêuticas. O método desenvolvido foi validado com relação à linearidade, exatidão (recuperação), precisão, adequação do sistema, especificidade e robustez. Os estudos de degradação forçada mostraram a estabilidade, indicando o poder do método.A novel stability-indicating high-performance liquid chromatographic assay method was developed and validated for quantitative determination of pramipexole dihydrochloride in bulk drugs and in pharmaceutical dosage form in the presence of degradation products. An isocratic, reversed phase HPLC method was developed to separate the drug from the degradation products, using an Ace5-C18 (250×4.6 mm, 5 µm) advance chromatography column, and 10 mmol L -1 ammonium acetate and acetonitrile (75:25 v/v) as a mobile phase. The detection was carried out at a wavelength of 260 nm. The pramipexole was subjected to stress conditions of hydrolysis (acid, base), oxidation, photolysis and thermal degradation. Degradation was observed for pramipexole in base, in acid and in 30% H 2 O 2 . The drug was found to be stable in the other stress conditions attempted. The degradation products were well resolved from the main peak. The percentage recovery of pramipexole was from (99.87 to 99.98%) in the pharmaceutical dosage form. The developed method was validated with respect to linearity, accuracy (recovery), precision, system suitability, specificity and robustness. The forced degradation studies prove the stability indicating power of the method.

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“…A high performance liquid chromatography/electrospray ionization tandem mass spectrometry method has been proposed by Nirogi etal., [8] for the estimation of PPE in human plasma. This method has high throughput but is less sensitive.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of Rapid LC-MS with Electrospray Ionization for the Quantification of Pramipexole in Human Plasma

Lavudu

Rani

Sekharan³

2014

ILCPA

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A rapid, accurate and precise LC-MS method is described for the quantitative determination of pramipexole in human plasma matrix using ropinirole as internal standard. Pramipexole and ropinirole were extracted from plasma by liquid-liquid extraction technique. The method was validated over the concentration range of 100-2514 pg/mL. The method was found to have acceptable accuracy, precision, linearity and selectivity. The mean extraction recovery from spiked plasma samples was in the range of 79.415-87.00 %. The intra-day accuracy of the assay ranged from 98.924 to 112.236 % and intra-day precision ranged from 3.489 to 6.756 %. Inter-day accuracy and precision results for quality control samples ranged between 100.340 and 107.443% of nominal and precision is observed to be 3.970-5.714 %. The pramipexole was found to be stable after several stability studies. The proposed method yielded a quick, simple and reliable protocol for estimating pramipexole concentrations in human plasma.

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Quantification of pramipexole in human plasma by liquid chromatography tandem mass spectrometry using tamsulosin as internal standard

Cited by 27 publications

References 11 publications

Development and validation of a sensitive LC‐MS/MS method with electrospray ionization for quantitation of pramipexole in human plasma: application to a clinical pharmacokinetic study

Development and validation of a sensitive LC‐MS/MS method with electrospray ionization for quantitation of pramipexole in human plasma: application to a clinical pharmacokinetic study

Stability-indicating HPLC determination of pramipexole dihydrochloride in bulk drug and pharmaceutical dosage form

Development and Validation of Rapid LC-MS with Electrospray Ionization for the Quantification of Pramipexole in Human Plasma

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