Accutest Research Laboratory

Ahmadābād, India

Accutest Research Laboratory

Ahmadābād, India

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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 Analysis | Year: 2017

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. © 2017 Xi'an Jiaotong University


Jangid A.G.,Accutest Research Laboratory | Suhagia B.N.,Gujarat University
Biomedical Chromatography | Year: 2017

A novel, precise, sensitive and accurate ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method has been developed for the simultaneous determination of a novel drug combination, candesartan (CAN) and chlorthalidone (CHL), in human plasma. Chromatographic separation was achieved on Waters Acquity UPLC BEH C18 (50×2.1mm, 1.7μm). Mobile phase consisting of 1mm ammonium acetate in water-acetonitrile (20:80v/v) was used. The total chromatographic runtime was 1.9min with retention times for CAN and CHL at 0.7 and 1.1min respectively. Ionization and detection of analytes and internal standards was performed on a triple quadrupole mass spectrometer, operating in the multiple reaction monitoring and negative ionization mode. Quantitation was done to monitor protonated precursor → product ion transition of m/z 439.2→309.0 for CAN, 337.0→189.8 for CHL and 443.2→312.1 for candesartan D4 and 341.0→189.8 for chlorthalidone D4. The method was validated over a wide dynamic concentration range of 2.0-540.0ng/mL for candesartan and 1.0-180.0ng/mL for chlorthalidone. The validated method was successfully applied for the assay of CAN and CHL in healthy volunteers. © 2017 John Wiley & Sons, Ltd.


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.


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.


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 Analysis | Year: 2016

An improved high performance liquid chromatography–tandem mass spectrometry (LC–MS/MS) method has been developed for sensitive and rapid determination of albendazole (ABZ) and its active metabolite, albendazole sulfoxide (ABZSO), in the positive ionization mode. The method utilized solid phase extraction (SPE) for sample preparation of the analytes and their deuterated internal standards (ISs) from 100 µL human plasma. The chromatography was carried out on Hypurity C18 column using acetonitrile-2.0 mM ammonium acetate, pH 5.0 (80:20, v/v) as the mobile phase. The assay exhibited a linear response over the concentration range of 0.200–50.0 ng/mL for ABZ and 3.00–600 ng/mL for ABZSO. The recoveries of the analytes and ISs ranged from 86.03%–89.66% and 89.85%–98.94%, respectively. Matrix effect, expressed as IS-normalized matrix factors, ranged from 0.985 to 1.042 for the both analytes. The method was successfully applied for two separate studies in healthy subjects using single dose of 400 mg conventional tablets and 400 mg chewable ABZ tablets, respectively. © 2016 Xi'an Jiaotong University


PubMed | Gujarat University, Kadi Sarva Vishwavidyalaya University, St Xaviers College and Accutest Research Laboratory
Type: | Journal: 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 4.6mm, 5 m) column using acetonitrile and 2.0mM 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 L 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 2h 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 50mg artesunate and 135 mg amodiaquine fixed dose formulation in 14 healthy subjects.


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.


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.

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