A validated RP-HPLC method for doxofylline analysis shows a linear response for concentrations from 1-200 μg/ml. The method, developed by Akhilesh Gupta, uses acetonitrile:formic acid (90:10) at pH-3.0 with detection at 274 nm and a flow rate of 1 ml/min. It was validated for accuracy, precision, and selectivity, and used to characterize a hydrolytic degradation product via LC-MS/MS.
Use Cases
- Validate analytical method performance based on reported linearity, precision, and accuracy metrics.
- Study drug degradation pathways based on the characterized hydrolytic degradation product.
- Develop stability-indicating assays for doxofylline in tablet formulations based on the described forced degradation study.
- Optimize chromatographic separation conditions based on the reported mobile phase composition and retention times.
Strengths
- Method validated for multiple parameters including accuracy, precision, linearity, and robustness as per ICH guidelines.
- Linear concentration range of 1-200 μg/ml with a reported %RSD from recovery studies of less than 1.
- Specific retention times provided for doxofylline (2.9 min) and its hydrolytic degradation product (3.68 min).
Limitations
- Row count and dataset size are unknown, which may limit suitability assessment.
- Column-level documentation is absent; field semantics must be inferred after download.
- Last update date is unknown; freshness unverified.
Provenance
- Source
- Akhilesh Gupta via paperswithcode
- Collection Method
- Laboratory analysis using RP-HPLC and LC-MS/MS instrumentation.