liquid chromatography–tandem mass spectrometry method for the quantitation of actarit in rabbit plasma: application to pharmacokinetics and metabolic stability
Actarit (ATR), 4‐acetylaminophenylacetic acid is an orally effective disease‐modifying anti‐rheumatic drug widely prescribed for the treatment of rheumatoid arthritis. The present study demonstrates the first report on a selective and sensitive liquid chromatography–tandem mass spectrometry method f...
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| Published in | Journal of mass spectrometry. Vol. 51; no. 1; pp. 69 - 78 |
|---|---|
| Main Authors | , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Wiley
2016
Blackwell Publishing Ltd Wiley Subscription Services, Inc |
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| Online Access | Get full text |
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| Abstract | Actarit (ATR), 4‐acetylaminophenylacetic acid is an orally effective disease‐modifying anti‐rheumatic drug widely prescribed for the treatment of rheumatoid arthritis. The present study demonstrates the first report on a selective and sensitive liquid chromatography–tandem mass spectrometry method for the quantification of ATR in rabbit plasma using p‐coumaric acid as an internal standard (IS). Following liquid–liquid extraction, chromatographic separation of the reconstituted samples was achieved isocratically on a Syncronis‐C18 column with a mobile phase consisting of aqueous ammonium acetate (10 mM, pH 4)‐ methanol and acetonitrile mixture (8 : 92, v/v) at a flow rate of 0.6 ml/min. ATR and IS were detected using electrospray ionization operated in negative multiple reaction monitoring mode. The calibration curve was linear (r² ≥ 0.990) over the concentration range of 1–4000 ng/ml with a lower limit of quantitation of 1 ng/ml. The mean extraction recovery of ATR and IS from rabbit plasma was greater than 85%. The method complied well with US Food and Drug Administration guidelines for selectivity, sensitivity, accuracy, precision, matrix effect, dilution integrity, carry‐over effect and stability. The method was successfully applied to in vitro metabolic stability (using rabbit liver microsomes) and in vivo pharmacokinetic study after oral administration of ATR at a dose of 10 mg/kg in New Zealand rabbits. Copyright © 2015 John Wiley & Sons, Ltd. |
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| AbstractList | Actarit (ATR), 4‐acetylaminophenylacetic acid is an orally effective disease‐modifying anti‐rheumatic drug widely prescribed for the treatment of rheumatoid arthritis. The present study demonstrates the first report on a selective and sensitive liquid chromatography–tandem mass spectrometry method for the quantification of ATR in rabbit plasma using p‐coumaric acid as an internal standard (IS). Following liquid–liquid extraction, chromatographic separation of the reconstituted samples was achieved isocratically on a Syncronis‐C18 column with a mobile phase consisting of aqueous ammonium acetate (10 mM, pH 4)‐ methanol and acetonitrile mixture (8 : 92, v/v) at a flow rate of 0.6 ml/min. ATR and IS were detected using electrospray ionization operated in negative multiple reaction monitoring mode. The calibration curve was linear (
r
2
≥ 0.990) over the concentration range of 1–4000 ng/ml with a lower limit of quantitation of 1 ng/ml. The mean extraction recovery of ATR and IS from rabbit plasma was greater than 85%. The method complied well with US Food and Drug Administration guidelines for selectivity, sensitivity, accuracy, precision, matrix effect, dilution integrity, carry‐over effect and stability. The method was successfully applied to
in vitro
metabolic stability (using rabbit liver microsomes) and
in vivo
pharmacokinetic study after oral administration of ATR at a dose of 10 mg/kg in
New Zealand
rabbits. Copyright © 2015 John Wiley & Sons, Ltd. Actarit (ATR), 4-acetylaminophenylacetic acid is an orally effective disease-modifying anti-rheumatic drug widely prescribed for the treatment of rheumatoid arthritis. The present study demonstrates the first report on a selective and sensitive liquid chromatography-tandem mass spectrometry method for the quantification of ATR in rabbit plasma using p-coumaric acid as an internal standard (IS). Following liquid-liquid extraction, chromatographic separation of the reconstituted samples was achieved isocratically on a Syncronis-C18 column with a mobile phase consisting of aqueous ammonium acetate (10mM, pH4)- methanol and acetonitrile mixture (8:92, v/v) at a flow rate of 0.6ml/min. ATR and IS were detected using electrospray ionization operated in negative multiple reaction monitoring mode. The calibration curve was linear (r super(2) greater than or equal to 0.990) over the concentration range of 1-4000ng/ml with a lower limit of quantitation of 1ng/ml. The mean extraction recovery of ATR and IS from rabbit plasma was greater than 85%. The method complied well with US Food and Drug Administration guidelines for selectivity, sensitivity, accuracy, precision, matrix effect, dilution integrity, carry-over effect and stability. The method was successfully applied to in vitro metabolic stability (using rabbit liver microsomes) and in vivo pharmacokinetic study after oral administration of ATR at a dose of 10mg/kg in New Zealand rabbits. Actarit (ATR), 4‐acetylaminophenylacetic acid is an orally effective disease‐modifying anti‐rheumatic drug widely prescribed for the treatment of rheumatoid arthritis. The present study demonstrates the first report on a selective and sensitive liquid chromatography–tandem mass spectrometry method for the quantification of ATR in rabbit plasma using p‐coumaric acid as an internal standard (IS). Following liquid–liquid extraction, chromatographic separation of the reconstituted samples was achieved isocratically on a Syncronis‐C18 column with a mobile phase consisting of aqueous ammonium acetate (10 mM, pH 4)‐ methanol and acetonitrile mixture (8 : 92, v/v) at a flow rate of 0.6 ml/min. ATR and IS were detected using electrospray ionization operated in negative multiple reaction monitoring mode. The calibration curve was linear (r2 ≥ 0.990) over the concentration range of 1–4000 ng/ml with a lower limit of quantitation of 1 ng/ml. The mean extraction recovery of ATR and IS from rabbit plasma was greater than 85%. The method complied well with US Food and Drug Administration guidelines for selectivity, sensitivity, accuracy, precision, matrix effect, dilution integrity, carry‐over effect and stability. The method was successfully applied to in vitro metabolic stability (using rabbit liver microsomes) and in vivo pharmacokinetic study after oral administration of ATR at a dose of 10 mg/kg in New Zealand rabbits. Copyright © 2015 John Wiley & Sons, Ltd. Actarit (ATR), 4-acetylaminophenylacetic acid is an orally effective disease-modifying anti-rheumatic drug widely prescribed for the treatment of rheumatoid arthritis. The present study demonstrates the first report on a selective and sensitive liquid chromatography-tandem mass spectrometry method for the quantification of ATR in rabbit plasma using p-coumaric acid as an internal standard (IS). Following liquid-liquid extraction, chromatographic separation of the reconstituted samples was achieved isocratically on a Syncronis-C18 column with a mobile phase consisting of aqueous ammonium acetate (10 mM, pH 4)- methanol and acetonitrile mixture (8 : 92, v/v) at a flow rate of 0.6 ml/min. ATR and IS were detected using electrospray ionization operated in negative multiple reaction monitoring mode. The calibration curve was linear (r(2) ≥ 0.990) over the concentration range of 1-4000 ng/ml with a lower limit of quantitation of 1 ng/ml. The mean extraction recovery of ATR and IS from rabbit plasma was greater than 85%. The method complied well with US Food and Drug Administration guidelines for selectivity, sensitivity, accuracy, precision, matrix effect, dilution integrity, carry-over effect and stability. The method was successfully applied to in vitro metabolic stability (using rabbit liver microsomes) and in vivo pharmacokinetic study after oral administration of ATR at a dose of 10 mg/kg in New Zealand rabbits. Copyright © 2015 John Wiley & Sons, Ltd. Actarit (ATR), 4‐acetylaminophenylacetic acid is an orally effective disease‐modifying anti‐rheumatic drug widely prescribed for the treatment of rheumatoid arthritis. The present study demonstrates the first report on a selective and sensitive liquid chromatography–tandem mass spectrometry method for the quantification of ATR in rabbit plasma using p‐coumaric acid as an internal standard (IS). Following liquid–liquid extraction, chromatographic separation of the reconstituted samples was achieved isocratically on a Syncronis‐C18 column with a mobile phase consisting of aqueous ammonium acetate (10 mM, pH 4)‐ methanol and acetonitrile mixture (8 : 92, v/v) at a flow rate of 0.6 ml/min. ATR and IS were detected using electrospray ionization operated in negative multiple reaction monitoring mode. The calibration curve was linear (r² ≥ 0.990) over the concentration range of 1–4000 ng/ml with a lower limit of quantitation of 1 ng/ml. The mean extraction recovery of ATR and IS from rabbit plasma was greater than 85%. The method complied well with US Food and Drug Administration guidelines for selectivity, sensitivity, accuracy, precision, matrix effect, dilution integrity, carry‐over effect and stability. The method was successfully applied to in vitro metabolic stability (using rabbit liver microsomes) and in vivo pharmacokinetic study after oral administration of ATR at a dose of 10 mg/kg in New Zealand rabbits. Copyright © 2015 John Wiley & Sons, Ltd. Actarit (ATR), 4-acetylaminophenylacetic acid is an orally effective disease-modifying anti-rheumatic drug widely prescribed for the treatment of rheumatoid arthritis. The present study demonstrates the first report on a selective and sensitive liquid chromatography-tandem mass spectrometry method for the quantification of ATR in rabbit plasma using p-coumaric acid as an internal standard (IS). Following liquid-liquid extraction, chromatographic separation of the reconstituted samples was achieved isocratically on a Syncronis-C18 column with a mobile phase consisting of aqueous ammonium acetate (10mM, pH4)- methanol and acetonitrile mixture (8:92, v/v) at a flow rate of 0.6ml/min. ATR and IS were detected using electrospray ionization operated in negative multiple reaction monitoring mode. The calibration curve was linear (r2≥0.990) over the concentration range of 1-4000ng/ml with a lower limit of quantitation of 1ng/ml. The mean extraction recovery of ATR and IS from rabbit plasma was greater than 85%. The method complied well with US Food and Drug Administration guidelines for selectivity, sensitivity, accuracy, precision, matrix effect, dilution integrity, carry-over effect and stability. The method was successfully applied to in vitro metabolic stability (using rabbit liver microsomes) and in vivo pharmacokinetic study after oral administration of ATR at a dose of 10mg/kg in New Zealand rabbits. Copyright © 2015 John Wiley & Sons, Ltd. |
| Author | Ramakrishna, Rachumallu Bhatta, Rabi Sankar Singh, Rajbir Durga Prasad, Yarra Bhateria, Manisha Puttrevu, Santosh kumar |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/26757074$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_1016_j_jpba_2016_03_002 crossref_primary_10_1002_chir_23257 crossref_primary_10_1016_j_jpba_2016_02_047 crossref_primary_10_1002_bmc_4295 crossref_primary_10_1016_j_jchromb_2016_07_030 crossref_primary_10_1080_13880209_2021_1990354 crossref_primary_10_1016_j_molliq_2022_119141 crossref_primary_10_1016_j_jpba_2019_112835 crossref_primary_10_1016_j_molliq_2021_117965 crossref_primary_10_1016_j_ajps_2018_05_009 |
| Cites_doi | 10.4103/0250-474X.84581 10.1016/j.jchromb.2015.07.042 10.1016/j.jpba.2013.04.033 10.1023/A:1018943613122 10.1016/j.jchromb.2015.03.018 10.1016/j.ijpharm.2007.10.014 10.1002/bmc.3182 10.1007/s11095-007-9291-7 10.3109/s101650050007 10.1124/dmd.30.7.831 |
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| Keywords | pharmacokinetics LC-MS/MS actarit rabbit plasma rheumatoid arthritis metabolic stability |
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| Snippet | Actarit (ATR), 4‐acetylaminophenylacetic acid is an orally effective disease‐modifying anti‐rheumatic drug widely prescribed for the treatment of rheumatoid... Actarit (ATR), 4-acetylaminophenylacetic acid is an orally effective disease-modifying anti-rheumatic drug widely prescribed for the treatment of rheumatoid... |
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| SubjectTerms | acetonitrile actarit Administration, Oral ammonium acetate Animals Antirheumatic Agents - administration & dosage Antirheumatic Agents - blood Antirheumatic Agents - metabolism Chromatography Chromatography, High Pressure Liquid - methods Coumaric Acids - chemistry Drugs Food and Drug Administration guidelines ionization LC-MS/MS Limit of Detection liquid chromatography Liquid-liquid extraction Liquid-Liquid Extraction - methods Liquids liver microsomes Male Mass spectrometry metabolic stability Metabolism methanol Microsomes, Liver - metabolism monitoring New Zealand White rabbit oral administration p-coumaric acid pharmacokinetics Pharmacology Phenylacetates - administration & dosage Phenylacetates - blood Phenylacetates - metabolism Propionates rabbit plasma Rabbits Reproducibility of Results rheumatoid arthritis Scientific imaging Stability tandem mass spectrometry Tandem Mass Spectrometry - methods |
| Title | liquid chromatography–tandem mass spectrometry method for the quantitation of actarit in rabbit plasma: application to pharmacokinetics and metabolic stability |
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