ArticleHeliyon2024
Quality by design (QbD) based development and validation of RP-HPLC method for buserelin acetate in polymeric nanoparticles: Release study.
Article in Heliyon, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 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.
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.
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Who cites it
2 citing papers in PubMed.
- Development of an AQbD-guided sustainable RP-HPLC method for simultaneous quantification of saracatinib and rapamycin in lipid-polymer hybrid nanocarriers.RSC advances · 2026Article
- Evaluation of Permeation Enhancers for Vaginal Delivery of Buserelin Acetate Using a Validated Chromatographic Method and Ex Vivo Porcine Model.Pharmaceutics · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Buserelin acetate (BA) is the first gonadotropin hormone to reduce the level of estrogen for the treatment of breast cancer. In the present study, RP-HPLC study has been developed and validated subsequently using the analytical quality by design (AQbD) approach. Initially, an analytical target profile (ATP) was defined that outlined the performance of the established method. The risk identification and its assessment were performed using the Ishikawa fishbone diagram and risk assessment method (RAM) to identify critical method parameters (CMPs) having influence on critical analytical attributes (CAAs). The flow rate and pH of buffer were identified as CMPs and retention time (Rt) and peak area (Pa) were recognized as CAAs. The optimization of the method was determined by response surface methodology based on central composite design (CCD). The chromatographic separation was achieved by mobile phase (water: acetonitrile, 80:20 %, v/v) and pH was adjusted using orthophosphoric acid with Zorbax Eclipse plus C18 (4.6 mm × 150 mm × 5 μm) column. Elution was monitored at 220 nm using a photodiode array (PDA) detector. The calibration curve showed the linearity (regression coefficient, R
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Registered trials
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