Evidence map›Paper›PMID 24302833›Full record

ArticleJournal of pharmacy & bioallied sciences2013

Bioanalytical method development and validation of alimemazine in human plasma by LC-MS/MS and its application in bioequivalence studies.

Bhupinder Singh, Sandeep Sharma, Naveen Dubey, Ashish Dwivedi, Rama S Lokhandae

Open access · goldAbstract read
In one paragraph

Article in Journal of pharmacy & bioallied sciences, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.9field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 10 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Bhupinder SinghBioanalytical Department, Jubiliant Clinsys Limited, Noida, New Delhi, India.
Sandeep Sharma
Naveen Dubey
Ashish Dwivedi
Rama S Lokhandae
Jubilant Life Sciences (India) · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe use of anti-histaminic agents has been increased significantly from last decades and till now no method is available for quantitation of ALZ in human plasma which can be applied in a bioequivalence study using LC-MS/MS.

objectiveThe present study is concerned with the development and validation of ALZ in human plasma by high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS). MATERIALS AND

methodsSample preparation involved the extraction with liquid-liquid extraction method by using ethyl acetate as an organic solvent. Chromatographic separation was performed on Atlantis® T3 5 μm 4.6 mm × 150 mm column with the mobile phase consisting of acetonitrile: (10 mm ammonium formate buffer: Formic acid: 99.9:00.1 v/v) 50:50 v/v. The interface used with the application programming interface 4000 LC-MS/MS was a turbo ion spray in which positive ions were measured in multiple reaction monitoring mode. The precursor to product ions transition of m/z 299.30 → 100.20 amu and 305.30 → 106.30 amu were used for ALZ and ALZ D6 respectively.

resultsThe method was validated over the concentration range of 20.013-10006.551 pg/mL. The mean percent recovery of ALZ was found 77.771% with a precision of 7.71% and the lower limit of quantification was 20.013 pg/mL. The intra- and inter-day precision of the method at three concentrations was 0.98-4.50% and 1.57-5.72% while the intra- and inter-day % accuracy was 99.02-93.82% and 101.78-106.96%. Stability of compounds was established in a series of stability studies. The application of this method was demonstrated in the bioequivalence study and was found suitable in a study of sample size as big as 30 enrolled volunteers.

conclusionFor the very first time, a sensitive, selective and robust Liquid Chromatography- Mass Spectrometry method for the determination of alimemazine (ALZ) in human plasma has been developed and validated using ALZ D6 as an internal standard.

Indexed as

Alimemazineantihistaminicantipruriticbioanalysisbioequivalencehigh-performance liquid chromatography tandem mass spectrometry

Identifiers

PMID24302833
PMCPMC3831738
OpenAlexW2049222222

What OpenQuestion holds

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LicenceCC BY-NC-SA
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.