ArticleJournal of pharmaceutical analysis2015
Identification, synthesis and characterization of process related impurities of benidipine hydrochloride, stress-testing/stability studies and HPLC/UPLC method validations.
Article in Journal of pharmaceutical analysis, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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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.
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Who cites it
3 citing papers in PubMed, 22 citations in OpenAlex.
- Tyr-Mpa Proximity-Induced AtypicalACS omega · 2026Article
- Rapid dissolving microneedle patch integrated with benidipine-loaded nanotransfersomes for transdermal drug delivery: optimization, characterizations, and preclinical bioavailability assessment.Drug delivery and translational research · 2026Article
- Identification, synthesis and characterization of process related desfluoro impurity of ezetimibe and HPLC method validations.Journal of pharmaceutical analysis · 2015Article
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Benidipine hydrochloride, used as an antihypertensive agent and long-acting calcium antagonist, is synthesized for commercial use as a drug substance in highly pure form. During the synthetic process development studies of benidipine, process related impurities were detected. These impurities were identified, synthesized and characterized and mechanisms of their formation were discussed in detail. After all standardization procedures, they were used as reference standards for analytical studies. In addition, a separate HPLC method was developed and validated for detection of residual 1-benzylpiperidin-3-ol (Ben-2), which is used during benidipine synthesis and controlled as a potential process related impurity. As complementary of this work, stress-testing studies of benidipine were carried out under specified conditions and a stability-indicating UPLC assay method was developed, validated and used during stability studies of benidipine.
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