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Patel D.,Pramukh Swami Science And Hd Patel Arts College | Patel D.,BA Research India Ltd | Sharma N.,BA Research India Ltd | Patel M.,Pramukh Swami Science And Hd Patel Arts College | And 4 more authors.
Acta Chromatographica | Year: 2014

A rapid, selective, and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay has been proposed for the determination of aripiprazole in human plasma. The analyte and propranolol as internal standard (IS) were extracted from 200 μL of human plasma via liquid-liquid extraction using methyl tert-butyl ether under alkaline conditions. The best chromatographic separation was achieved on an Aquasil C18 (100 × 2.1 mm, 5 μm) column using methanol-deionized water containing 2 mM ammonium trifluoroacetate and 0.02% formic acid (65:35, v/v) as the mobile phase under isocratic conditions. Detection of analyte and IS was done by tandem mass spectrometry, operating in positive ion and multiple reaction monitoring (MRM) acquisition mode. The method was fully validated for its selectivity, interference check, sensitivity, carryover check, linearity, precision and accuracy, reinjection reproducibility, recovery, matrix effect, ion suppression/enhancement, stability, ruggedness, and dilution integrity. The assay was linear over the concentration range of 0.10-100 ng mL-1 for aripiprazole. The intra-batch and inter-batch precision (%CV) was 4.8%, while the mean extraction recovery was >96% for aripiprazole across quality control levels. The method was successfully applied to a bioequivalence study of 10 mg aripiprazole orally disintegrating tablet formulation in 27 healthy Indian subjects under fasting and fed condition. The reproducibility in the measurement of study data was demonstrated by reanalysis of 260 incurred samples. Source


Patel D.S.,Pramukh Swami Science And Hd Patel Arts College | Patel D.S.,BA Research India Ltd | Sharma N.,BA Research India Ltd | Patel M.C.,Pramukh Swami Science And Hd Patel Arts College | And 4 more authors.
Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences | Year: 2011

A selective and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay for the determination of cycloserine in human plasma is developed using niacin as internal standard (IS). The analyte and IS were extracted from 500μL of human plasma via solid phase extraction on Waters Oasis MCX cartridges. Chromatographic separation was achieved on a Peerless Basic C18 (100 mm × 4.6 mm, 3μm) column under isocratic conditions. Detection of analyte and IS was done by tandem mass spectrometry, operating in positive ion and multiple reaction monitoring (MRM) acquisition mode. The protonated precursor to product ion transitions monitored for cycloserine and niacin were at m/z 103.1 → 75.0 and 124.1 → 80.1 respectively. The method was fully validated for its selectivity, interference check, sensitivity, carryover check, linearity, precision and accuracy, reinjection reproducibility, recovery, matrix effect, ion suppression/enhancement, stability and dilution integrity. The limit of detection (LOD) and lower limit of quantitation of the method were 0.0013 and 0.20μg/mL respectively with a linear dynamic range of 0.20-30.00μg/mL for cycloserine. The intra-batch and inter-batch precision (%CV) across six quality control levels was less than 8.0% for cycloserine. The method was successfully applied to a bioequivalence study of 250. mg cycloserine capsule formulation in 24 healthy Indian male subjects under fasting condition. © 2011 Elsevier B.V. Source


Patel D.S.,Pramukh Swami Science And Hd Patel Arts College | Patel D.S.,BA Research India Ltd | Sharma N.,BA Research India Ltd | Patel M.C.,Pramukh Swami Science And Hd Patel Arts College | And 4 more authors.
Bioanalysis | Year: 2011

A simple, selective and sensitive LC-MS/MS assay has been developed for the determination of minocycline in human plasma. Plasma samples were prepared by protein precipitation, followed by chromatographic separation on a HyPURITY™ C8 (100 mm × 4.6 mm, 5 μm) column under isocratic conditions. The LOD and LLOQ of the method were 0.50 and 20.0 ng/ml, respectively. The intra-batch and inter-batch precision (% coefficient of variation) across quality control levels was less than 8.0%. For a set of incurred samples the percentage change in concentration was within ± 9.0%. The method was successfully applied to a bioequivalence study of 135 mg minocycline tablet formulation in 14 healthy Indian males. The reproducibility in the measurement of study data was demonstrated by incurred sample reanalysis. © 2011 Future Science Ltd. Source


Patel D.S.,Pramukh Swami Science And Hd Patel Arts College | Patel D.S.,Cliantha Research Ltd | Sharma N.,Cliantha Research Ltd | Patel M.C.,Pramukh Swami Science And Hd Patel Arts College | And 4 more authors.
Journal of Chromatographic Science | Year: 2013

A reliable and sensitive liquid chromatography-tandem mass spectrometry assay has been proposed for the selective determination of diflunisal in the presence of its glucuronide metabolites. The analyte and clofibric acid as internal standard (IS) are extracted from 50 μL of human plasma by solid-phase extraction. Chromatographic separation is conducted on a Prodigy ODS 3V column (150 × 4.6 mm, 5 μm) under isocratic conditions. The possible interference of acyl glucuronide and phenolic glucuronide, the two major inactive metabolites of diflunisal, is also checked in plasma samples. Detection of the analyte and IS is achieved by tandem mass spectrometry, operating in negative ionization and multiple reaction monitoring acquisition mode. The limits of detection and quantitation of the method are 0.10 and 1.00 μg/mL, respectively, with a linear dynamic range of 1.00-160 μg/mL for diflunisal. The intra-batch and inter-batch precision (percent coefficient of variation) is ≤4.2% and the mean recovery is >92% for diflunisal across quality control levels. The method is successfully applied to a bioequivalence study of a 500 mg diflunisal tablet formulation in 30 healthy Indian male subjects under fasting conditions. The reproducibility in the measurement of study data is demonstrated by the reanalysis of 120 incurred samples. © 2012 © The Author [2012]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com. Source


Patel D.S.,Pramukh Swami Science And Hd Patel Arts College | Patel D.S.,Cliantha Research Ltd | Sharma N.,Cliantha Research Ltd | Patel M.C.,Pramukh Swami Science And Hd Patel Arts College | And 4 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2012

A rapid, selective and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay has been proposed for the determination of bumetanide in human plasma using tamsulosin as internal standard (IS). The analyte and IS were extracted from 200 μL of human plasma via solid phase extraction and the chromatographic separation was achieved on Peerless Basic C18 (100. mm × 4.6 mm, 3 μm) column under isocratic conditions. Detection of bumetanide and IS was done by tandem mass spectrometry, operating in positive ionization and multiple reaction monitoring (MRM) acquisition mode. The protonated precursor to product ion transitions monitored for bumetanide and IS were m/ z 365.2 → 240.2 and 409.2 → 228.2 respectively. The method was fully validated as per the US FDA guidelines. The limit of detection and lower limit of quantitation of the method were 0.03 and 0.30. ng/mL respectively with a linear dynamic range of 0.30-200.0. ng/mL for bumetanide. The intra-batch and inter-batch precision (% CV) was ≤6.9% while the mean extraction recovery was >90% across quality control levels. The method is selective in presence of four diuretic drugs and some commonly used medications by healthy volunteers. It was successfully applied to a bioequivalence study of 2. mg bumetanide tablet formulation in 10 healthy Indian male subjects under fasting condition. The reproducibility in the measurement of study data was demonstrated by reanalysis of 42 incurred samples. © 2012 Elsevier B.V. Source

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