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Ahmadābād, India

Rathod D.M.,Kadi Sarva Vishwavidyalaya University | Rathod D.M.,Accutest Research Laboratory | Patel K.R.,Accutest Research Laboratory | Mistri H.N.,Accutest Research Laboratory | And 3 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2016

A sensitive and high throughput bioanalytical method has been developed for reliable determination of amodiaquine (AQ), N-desethylamodiaquine (DEAQ), artesunate (AS) and dihydroartemisinin (DHA) in human plasma by LC-MS/MS. The method employs a solid phase extraction procedure without an evaporation step and with optimum use of organic solvents to circumvent degradation of artemisinin derivatives. The analytes and their deuterated internal standards (ISs) were analyzed on Hypersil Gold (100 mm × 4.6 mm, 5 μm) column using acetonitrile and 2.0 mM ammonium formate (pH 2.50) in 80:20 (v/v) ratio as the mobile phase. A triple quadrupole mass spectrometer equipped with an electrospray ionization interface was used to detect and quantify the analytes. The method was established over the concentration range of 0.250-30.0 ng/mL, 1.50-180 ng/mL, 2.00-600 ng/mL and 5.00-1400 ng/mL for AQ, DEAQ, AS and DHA respectively using 250 μL human plasma. The intra-day and inter-day accuracy and precision (% CV) across quality controls varied from 93.3-105.0% and 1.7-8.3 respectively for all the analytes. The stability was assessed in whole blood as well as in plasma samples under different conditions. All four analytes were stable in whole blood up to 2 h on melting ice. The long term stability in plasma was ascertained up to 90 days. IS-normalized matrix factors ranged from 0.988-1.023 for all the analytes. The method was successfully applied to a bioequivalence study using 50 mg artesunate and 135 mg amodiaquine fixed dose formulation in 14 healthy subjects. © 2016 Elsevier B.V. Source


Patel B.,Accutest Research Laboratory | Suhagia B.N.,Gujarat University | Jangid A.G.,Accutest Research Laboratory | Mistri H.N.,Accutest Research Laboratory
Biomedical Chromatography | Year: 2015

The objective of the present work was to carry out systematic evaluation to eliminate matrix effect owing to plasma phospholipids as observed during sample preparation and to develop a cross-talk-free sensitive, selective and rapid bioanalytical method for the simultaneous determination of zolmitriptan (ZT) and N-desmethyl zolmitriptan (DZT) in human plasma by liquid chromatography-tandem mass spectrometry using naratriptan as internal standard (IS). The analytes and IS were quantitatively extracted from 200μL human plasma by solid phase extraction. No cross-talk was found between ZT and DZT having identical product ions. Quantitation was performed on a triple quadrupole mass spectrometer employing electrospray ionization technique, operating in multiple reaction monitoring and positive ion mode. The total chromatographic run time was 2.5min. The method was fully validated for sensitivity, selectivity, specificity, linearity, accuracy, precision, recovery, matrix effect, dilution integrity and stability studies. The method was validated over a dynamic concentration range of 0.1-15ng/mL for ZT and DZT. The method was successfully applied to a bioequivalence study of 2.5mg ZT tablet formulation in 18 healthy Indian male subjects under fasting conditions. Assay reproducibility was assessed by reanalysis of 62 incurred samples. © 2015 John Wiley & Sons, Ltd. Source


Patel B.,St Xaviers College | Patel B.,Accutest Research Laboratory | Suhagia B.N.,Gujarat University | Jangid A.G.,Accutest Research Laboratory | And 2 more authors.
Biomedical Chromatography | Year: 2016

The objective of the present work was to carry out systematic evaluation to eliminate matrix effect owing to plasma phospholipids as observed during sample preparation and to develop a cross-talk-free sensitive, selective and rapid bioanalytical method for the simultaneous determination of zolmitriptan (ZT) and N-desmethyl zolmitriptan (DZT) in human plasma by liquid chromatography-tandem mass spectrometry using naratriptan as internal standard (IS). The analytes and IS were quantitatively extracted from 200μL human plasma by solid phase extraction. No cross-talk was found between ZT and DZT having identical product ions. Quantitation was performed on a triple quadrupole mass spectrometer employing electrospray ionization technique, operating in multiple reaction monitoring and positive ion mode. The total chromatographic run time was 2.5 min. The method was fully validated for sensitivity, selectivity, specificity, linearity, accuracy, precision, recovery, matrix effect, dilution integrity and stability studies. The method was validated over a dynamic concentration range of 0.1-15ng/mL for ZT and DZT. The method was successfully applied to a bioequivalence study of 2.5mg ZT tablet formulation in 18 healthy Indian male subjects under fasting conditions. Assay reproducibility was assessed by reanalysis of 62 incurred samples. © 2016 John Wiley & Sons, Ltd. Source


Mistri H.N.,Gujarat University | Mistri H.N.,Accutest Research Laboratory | Jangid A.G.,Accutest Research Laboratory | Pudage A.,Accutest Research Laboratory | And 2 more authors.
Microchemical Journal | Year: 2010

A highly sensitive, selective and high-throughput liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for simultaneous quantification of sulfamethoxazole (SMZ) and trimethoprim (TMP) has been developed and validated using imipramine as an internal standard. The analytes were extracted from 50 μL human plasma using solid phase extraction (SPE) and separated on Thermo Hypersil Gold C18 (50 mm × 4.6 mm, 5 μm) column under isocratic conditions in a run time of 2.5 min. Detection was carried out by tandem mass spectrometer, interfaced with electro spray ionization and operating in positive ionization mode. The calibration curves were linear over the concentration range of 0.88-80 μg/mL for SMZ and 0.03-30 μg/mL for TMP. The intra- and inter-day accuracy and precision (% CV) evaluated at four quality control levels were within 93.5-105.0% and 1.3-7.2% respectively. The absolute recovery was greater than 81% for both the analytes at two concentration levels. Stability of SMZ and TMP was assessed under different storage conditions. The validated method was successfully applied for a bioavailability study in 12 healthy volunteers after oral administration of 800 mg of SMZ and 160 mg of TMP succinate tablet formulations under fasting condition. © 2009 Elsevier B.V. All rights reserved. Source

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