Development and Validation of an RP‐HPLC Method for Organic Impurity Profiling in Baclofen Utilizing Robustness Through a Quality‐by‐Design (QbD) Approach: A Comprehensive Forced Degradation Assessment Article Swipe
Santhosh Kumar Ettaboina
,
Satyasree Nannapaneni
,
Naresh Kumar Katari
,
Vijay Kumar Chollety
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1002/bmc.70129
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1002/bmc.70129
Strong understandings of science and risk evaluation methodologies are needed to design an analytical method for pharmaceutical quality assessment. This article provides an HPLC method for separating and quantifying baclofen and related impurities. The technique used a Waters Symmetry C 18 column, 250 × 4.6 mm, 5 μm in gradient mode. Mobile Phase A was prepared by dissolving 0.0128 M of 1‐octane sulfonic acid sodium salt in water, followed by the addition of 1 mL of orthophosphoric acid and 2 mL of tetrabutylammonium hydroxide to make up to a solution of 1 L. Mobile Phase B was a homogenous mixture of methanol and water in a 900:100 (v/v) ratio. A 0.7‐mL/min flow rate was maintained for 60 min. The sample cooler and column temperatures were kept at 25°C and 32°C with a 10‐μL injection volume. The detecting wavelength was 225 nm. The drug product and material were subjected to acidity, base, oxidation, heat, and photolysis according to International Conference on Harmonization (Q2) criteria. A linear response ( R 2 > 0.999), accuracy (recoveries 97.1%–102.5%), precision (RS ≤ 5.0%), sensitivity, and specificity were demonstrated by the proposed method. This method ensures reliable analytical performance by cleanly separating compounds. Final method conditions were assessed using a full‐factorial design. Graphical optimization from the design space identified robust technique conditions.
Related Topics
Concepts
Chemistry
Chromatography
Forced degradation
Methanol
Quality by Design
High-performance liquid chromatography
Factorial experiment
Fractional factorial design
Impurity
Analytical Chemistry (journal)
Reversed-phase chromatography
Computer science
Machine learning
Particle size
Physical chemistry
Organic chemistry
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1002/bmc.70129
- https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/bmc.70129
- OA Status
- bronze
- Cited By
- 7
- References
- 21
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4411554502
All OpenAlex metadata
Raw OpenAlex JSON
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https://openalex.org/W4411554502Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1002/bmc.70129Digital Object Identifier
- Title
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Development and Validation of an RP‐HPLC Method for Organic Impurity Profiling in Baclofen Utilizing Robustness Through a Quality‐by‐Design (QbD) Approach: A Comprehensive Forced Degradation AssessmentWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2025Year of publication
- Publication date
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2025-06-23Full publication date if available
- Authors
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Santhosh Kumar Ettaboina, Satyasree Nannapaneni, Naresh Kumar Katari, Vijay Kumar CholletyList of authors in order
- Landing page
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https://doi.org/10.1002/bmc.70129Publisher landing page
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https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/bmc.70129Direct link to full text PDF
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YesWhether a free full text is available
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bronzeOpen access status per OpenAlex
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https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/bmc.70129Direct OA link when available
- Concepts
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Chemistry, Chromatography, Forced degradation, Methanol, Quality by Design, High-performance liquid chromatography, Factorial experiment, Fractional factorial design, Impurity, Analytical Chemistry (journal), Reversed-phase chromatography, Computer science, Machine learning, Particle size, Physical chemistry, Organic chemistryTop concepts (fields/topics) attached by OpenAlex
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7Total citation count in OpenAlex
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2025: 7Per-year citation counts (last 5 years)
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21Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.32°C | 130 |
| abstract_inverted_index.Final | 198 |
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