Evidence map›Paper›PMID 29403992›Full record

ArticleJournal of pharmaceutical analysis2016

Validation of a liquid chromatographic method for the pharmaceutical quality control of products containing elacridar.

Emilia Sawicki, Michel J Hillebrand, Hilde Rosing, Jan H M Schellens, Bastiaan Nuijen, Jos H Beijnen

Abstract read
In one paragraph

Article in Journal of pharmaceutical analysis, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

6 authors.

Emilia SawickiDepartment of Pharmacy & Pharmacology, The Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.
Michel J HillebrandDepartment of Pharmacy & Pharmacology, The Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.
Hilde RosingDepartment of Pharmacy & Pharmacology, The Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.
Jan H M SchellensDivision of Clinical Pharmacology, Department of Medical Oncology, The Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.
Bastiaan NuijenDepartment of Pharmacy & Pharmacology, The Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.
Jos H BeijnenDepartment of Pharmacy & Pharmacology, The Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Many anticancer drugs have an impaired bioavailability and poor brain penetration because they are substrates to drug efflux pumps such as P-glycoprotein and Breast Cancer Resistance Protein. Elacridar is a strong inhibitor of these two drug efflux pumps and therefore has great potential to improve oral absorption and brain penetration of many anticancer drugs. Currently, a clinical formulation of elacridar is unavailable and therefore the pharmaceutical development of a drug product is highly warranted. This also necessitates the availability of an analytical method for its quality control. A reverse-phase high-performance liquid chromatographic method with ultraviolet detection was developed for the pharmaceutical quality control of products containing elacridar as the active pharmaceutical ingredient. The analytical method was validated for linearity, accuracy, precision, selectivity, carry-over, stability of stock and reference solutions, stability of the final extract, stability-indicating capability and impurity testing. We found that elacridar is unstable in aqueous solutions that are exposed to light because a hydroxylation product of elacridar is formed. Therefore, sample solutions with elacridar must be protected from light.

Indexed as

DissolutionGF120918HPLC–UVHydroxylationSolid dispersion

Identifiers

PMID29403992
PMCPMC5762608

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.