Challenges in the simultaneous quantitation of sumatriptan and naproxen in human plasma: Application to a bioequivalence study

Patel, Daxesh P.; Sharma, Primal; Sanyal, Mallika; Singhal, Puran; Shrivastav, Pranav S.

doi:10.1016/j.jchromb.2012.06.041

Cited by 23 publications

(17 citation statements)

References 58 publications

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“…In our studies of migration, pretreatment with NSAIDs reduced F‐actin polymerization in neutrophils, in response to C5a and CXCL8. Furthermore, the NSAIDs were used at a low therapeutic dose (50 µmol L −1 , previously shown to inhibit COX‐1 in vitro ) (Kawai et al ., ; Furst et al ., ; Ottonello et al ., ), close to the circulating concentrations detectable in humans (34–58 µM for oxaprozin, 96 µM for ibuprofen, 260 µM for naproxen) (Lötsch et al ., ; Patel et al ., ). Importantly, there was no loss of viability in neutrophils exposed to these concentrations of NSAIDs, in all experiments performed.…”

Section: Discussionmentioning

confidence: 99%

Neutrophil migration towards C5a and CXCL8 is prevented by non‐steroidal anti‐inflammatory drugs via inhibition of different pathways

Bertolotto

Contini

Ottonello

et al. 2014

British J Pharmacology

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BACKGROUND AND PURPOSENon-steroidal anti-inflammatory drugs (NSAIDs) have been shown to induce PG-independent anti-inflammatory actions. Here, we investigated the role of three different NSAIDs (naproxen, ibuprofen and oxaprozin) on neutrophil responses to CXCL8 and C5a. EXPERIMENTAL APPROACHHuman neutrophils were isolated from healthy volunteers by dextran and Ficoll-Hypaque density gradients. Neutrophils were pre-incubated with different concentrations (1-100 µM) of NSAIDs or kinase inhibitors. Neutrophil degranulation into supernatants was tested by ELISA and zymography. Neutrophil chemotaxis was determined using Boyden chambers. F-actin polymerization was determined by Alexa-Fluor 488-conjugated phalloidin fluorescent assay. Integrin expression was assessed by flow cytometry. The phosphorylation of intracellular kinases was studied by Western blot. KEY RESULTSPretreatment with NSAIDs did not affect neutrophil degranulation, but inhibited neutrophil migration and polymerization of F-actin, in response to CXCL8 and C5a. Pretreatment with different NSAIDs prevented C5a-induced integrin (CD11b) up-regulation, while only ibuprofen reduced CXCL8-induced CD11b up-regulation. Pre-incubation with naproxen or oxaprozin, but not ibuprofen, inhibited the PI3K/Akt-dependent chemotactic pathways. Both endogenous (released in cell supernatants) or exogenous (added to cell cultures) PGE2 did not affect C5a-or CXCL8-induced activities. Short-term incubation with NSAIDs did not affect neutrophil PGE2 release. CONCLUSION AND IMPLICATIONSTreatment with NSAIDs reduced C5a-and CXCL8-induced neutrophil migration and F-actin polymerization via different mechanisms. Inhibition by ibuprofen was associated with integrin down-regulation, while naproxen and oxaprozin blocked the PI3K/Akt pathway. Both NSAID actions were independent of COX inhibition and PGE2 release.

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Section: Discussionmentioning

confidence: 99%

Neutrophil migration towards C5a and CXCL8 is prevented by non‐steroidal anti‐inflammatory drugs via inhibition of different pathways

Bertolotto

Contini

Ottonello

et al. 2014

British J Pharmacology

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“…Sample pretreatment in the previous studies was based on solid‐phase extraction (Gopinath et al ., ; Patel et al ., ), protein precipitation (Bae et al ., ; Elsinghorst et al ., ; Helmy and El Bedaiwy, ; Martín et al ., ; Palma‐Aguirre et al ., ; Sakaguchi et al ., ; Sultana et al ., ; Xiong et al ., ) and liquid–liquid extraction (Carrasco‐Portugal et al ., ; Marzo et al ., ; Niazi et al ., ; Setiawati et al , ; Shimek et al ., ; Sun et al ., ; Yilmaz et al ., ; Toothaker et al ., ). Solid‐phase extraction methods are very effective and provide a selective cleanup, but they require the use of expensive instruments and cartridges.…”

Section: Discussionmentioning

confidence: 99%

“…No significant changes in the chromatographic separation were observed, which indirectly confirmed the appropriate selection of the sample pretreatment procedure. Although the recoveries of several previously reported sample preparation methods (Elsinghorst et al ., ; Martín et al ., ; Marzo et al ., ; Patel et al ., ; Sakaguchi et al ., ; Sun et al ., ; Yilmaz et al ., ) were higher (>90%) compared with the presented method, the sensitivity of the developed assay is sufficient for the planned purposes and consistent for all studied concentration levels.…”

Section: Discussionmentioning

confidence: 99%

“…The majority of methods for naproxen quantification in human plasma or serum samples are based on high‐performance liquid chromatography technique (HPLC) with various detections, such as chemiluminescent (Xiong et al ., ), fluorometric (Sakaguchi et al ., ; Shimek et al ., ; Toothaker et al ., ), mass spectrometric (Choi et al ., ; Elsinghorst et al ., ; Gopinath et al ., ; Patel et al ., ) and the most common ultraviolet (UV) (Bae et al ., ; Carrasco‐Portugal et al ., ; Helmy and El Bedaiwy, ; Martín et al ., ; Marzo et al ., ; Niazi et al ., ; Palma‐Aguirre et al ., ; Setiawati et al ., ; Sultana et al ., ; Sun et al ., ; Yilmaz et al ., ). For the HPLC‐UV assays the lowest reported lower limit of quantitation (LLOQ) value is 100 ng/mL (Sun et al ., ; Yilmaz et al ., ).…”

Section: Introductionmentioning

confidence: 99%

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Validated HPLC‐UV method for determination of naproxen in human plasma with proven selectivity against ibuprofen and paracetamol

Filist

Szlaska

Kaza

et al. 2015

Biomedical Chromatography

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Estimating the influence of interfering compounds present in the biological matrix on the determination of an analyte is one of the most important tasks during bioanalytical method development and validation. Interferences from endogenous components and, if necessary, from major metabolites as well as possible co-administered medications should be evaluated during a selectivity test. This paper describes a simple, rapid and cost-effective HPLC-UV method for the determination of naproxen in human plasma in the presence of two other analgesics, ibuprofen and paracetamol. Sample preparation is based on a simple liquid-liquid extraction procedure with a short, 5 s mixing time. Fenoprofen, which is characterized by a similar structure and properties to naproxen, was first used as the internal standard. The calibration curve is linear in the concentration range of 0.5-80.0 µg/mL, which is suitable for pharmacokinetic studies following a single 220 mg oral dose of naproxen sodium. The method was fully validated according to international guidelines and was successfully applied in a bioequivalence study in humans. Copyright © 2015 John Wiley & Sons, Ltd.

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“…The procedures were similar to those in our previous report (Patel, Sharma, Sanyal, Singhal, & Shrivastav, 2012) and are briefly described in Appendix A in the Supporting Information.…”

Section: Methodsmentioning

confidence: 99%

Simultaneous determination of etonogestrel and ethinyl estradiol in human plasma by UPLC‐MS/MS and its pharmacokinetic study

Nair

Patel

Gonzalez

et al. 2018

Biomedical Chromatography

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A selective, sensitive and rapid ultra-performance liquid chromatography tandem mass spectrometry method was developed and validated for the simultaneous determination of etonogestrel (ENG) and ethinyl estradiol (EE) in human plasma. The analytes and their deuterated internal standards, ENG-d7 and EE-d4, were extracted from plasma samples by solid-phase extraction on HyperSep™ Retain PEP cartridges. The chromatographic analysis was performed on an Acquity UPLC HSS Cyano column, 100 Å (50 × 2.1 mm, 1.8 μm), column using gradient mobile phase, acetonitrile and 2.0 mm ammonium trifluoroacetate at 0-1.7 min (65:35, v/v) and 1.8-2.7 min (95:5, v/v) with 0.250 mL/min flow rate. Analytes and IS protonated precursor → product ion transitions (ENG, m/z 325.2 → 257.2; EE, m/z 530.2 → 171.2; ENG-d7, m/z 332.2 → 263.2; EE-d4, m/z 534.2 → 171.2) were monitored on a Triple Quadrupole Mass spectrometer (TQMS), operating in multiple reaction monitoring and positive ionization mode. The calibration curves were established at 10.00-2500 pg/mL for ENG and 1.500-150.0 pg/mL for EE with a correlation coefficient (r ) ≥0.9996 for both. The validated method was successfully applied to support a bioequivalence study of 0.15 mg ENG and EE 0.03 mg tablet formulation, administered in 24 healthy Indian females. Method reliability was assessed by reanalysis of 94 incurred study samples.

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Challenges in the simultaneous quantitation of sumatriptan and naproxen in human plasma: Application to a bioequivalence study

Cited by 23 publications

References 58 publications

Neutrophil migration towards C5a and CXCL8 is prevented by non‐steroidal anti‐inflammatory drugs via inhibition of different pathways

Neutrophil migration towards C5a and CXCL8 is prevented by non‐steroidal anti‐inflammatory drugs via inhibition of different pathways

Validated HPLC‐UV method for determination of naproxen in human plasma with proven selectivity against ibuprofen and paracetamol

Simultaneous determination of etonogestrel and ethinyl estradiol in human plasma by UPLC‐MS/MS and its pharmacokinetic study

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