Application of an LC–MS/MS method for reliable determination of amodiaquine, N -desethylamodiaquine, artesunate and dihydroartemisinin in human plasma for a bioequivalence study in healthy Indian subjects

Rathod, Dhiraj M.; Patel, Keyur R.; Mistri, Hiren N.; Jangid, Arvind G.; Shrivastav, Pranav S.; Sanyal, Mallika

doi:10.1016/j.jpba.2016.02.021

Cited by 7 publications

(2 citation statements)

References 37 publications

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“…The method was validated as per the current regulatory guidance [13] , [14] . The procedures were similar to those of our previous report [15] and are briefly described. System suitability experiment was performed by injecting six consecutive injections, using extracted sample of ALV/PHA (15,000 pg/mL) and IS (8.00 ng/mL) at the beginning of each batch.…”

Section: Methodsmentioning

confidence: 91%

An improved LC-MS/MS method for the quantification of alverine and para hydroxy alverine in human plasma for a bioequivalence study☆

Rathod

Patel

Mistri

et al. 2017

Journal of Pharmaceutical Analysis

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A highly sensitive and selective high performance liquid chromatography-tandem mass spectrometry method was developed and validated for the quantification of alverine (ALV) and its active metabolite, para hydroxy alverine (PHA), in human plasma. For sample preparation, solid phase extraction of analytes was performed on Phenomenex Strata-X cartridges using alverine-d5 as the internal standard. The analytes were separated on Symmetry Shield RP18 (150 mm×3.9 mm, 5 µm) column with a mobile phase consisting of acetonitrile and 10 mM ammonium formate (65:35, v/v). Detection and quantitation was done by electrospray ionization mass spectrometry in the positive mode using multiple reaction monitoring. The assay method was fully validated over the concentration range of 15.0–15,000 pg/mL for ALV and 30.0–15,000 pg/mL for PHA. The intra-day and inter-day accuracy and precision (% CV) ranged from 94.00% to 96.00% and 0.48% to 4.15% for both the analytes. The mean recovery obtained for ALV and PHA was 80.59% and 81.26%, respectively. Matrix effect, expressed as IS-normalized matrix factor ranged from 0.982 to 1.009 for both the analytes. The application of the method was demonstrated for the specific analysis of ALV and PHA for a bioequivalence study in 52 healthy subjects using 120 mg ALV capsules. The assay reproducibility was also verified by reanalysis of 175 incurred subject samples.

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Section: Methodsmentioning

confidence: 91%

An improved LC-MS/MS method for the quantification of alverine and para hydroxy alverine in human plasma for a bioequivalence study☆

Rathod

Patel

Mistri

et al. 2017

Journal of Pharmaceutical Analysis

Self Cite

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“…Some methods use more efficient sample extraction technique (e.g., SPE) and still maintained very good sensitivity. However, considering how time consuming SPE techniques can be, consisting of several labour-intensive steps and the total cost of SPE [13] , [14] this might have an impact on time and cost for larger studies.…”

Section: Introductionmentioning

confidence: 99%

High-throughput quantitation method for amodiaquine and desethylamodiaquine in plasma using supported liquid extraction technology

Kaewkhao

Tärning

Blessborn

2021

Journal of Chromatography B

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Highlights Supported liquid extraction is easy to use as visual phase separation isn't needed. Automated sample preparation allows fast sample process and subsequent analysis. Automated liquid handling coupled with LC-MS/MS as high-throughput method. Washout gradient in LC method removes strongly retaining compounds from the column. Sensitive method of 1.08/1.41 ng/ml for amodiaquine/desethylamodiaquine.

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Development and applications of liquid chromatography-mass spectrometry for simultaneous analysis of anti-malarial drugs in pharmaceutical formulations

Chutvirasakul

Joseph

Parr

et al. 2021

Journal of Pharmaceutical and Biomedical Analysis

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Application of an LC–MS/MS method for reliable determination of amodiaquine, N -desethylamodiaquine, artesunate and dihydroartemisinin in human plasma for a bioequivalence study in healthy Indian subjects

Cited by 7 publications

References 37 publications

An improved LC-MS/MS method for the quantification of alverine and para hydroxy alverine in human plasma for a bioequivalence study☆

An improved LC-MS/MS method for the quantification of alverine and para hydroxy alverine in human plasma for a bioequivalence study☆

High-throughput quantitation method for amodiaquine and desethylamodiaquine in plasma using supported liquid extraction technology

Development and applications of liquid chromatography-mass spectrometry for simultaneous analysis of anti-malarial drugs in pharmaceutical formulations

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