A validated RP-HPLC method for determining doxofylline and its acid degradation product, developed by Akhilesh Gupta. The method uses a mobile phase of acetonitrile and formic acid, with detection at 274 nm, a flow rate of 1 ml/min, and shows linearity for concentrations from 1 to 200 µg/ml. The acid degradation pathway was characterized using LC-MS/MS, with retention times of 2.9 minutes for the drug and 4.8 minutes for the degradation product.
Use Cases
- Validate HPLC methods for routine quality control analysis based on described accuracy, precision, and linearity parameters.
- Study forced degradation pathways of pharmaceutical compounds based on the LC-MS/MS characterization of acid degradation products.
- Optimize chromatographic separation conditions based on the described mobile phase composition and retention times.
- Perform recovery studies on dosage forms based on the reported % RSD of less than 1.
Strengths
- Method validated per ICH guidelines for accuracy, precision, linearity, ruggedness, robustness, and selectivity.
- Recovery studies show a % RSD of less than 1, indicating high precision.
- Provides specific analytical parameters: linear range of 1-200 µg/ml, flow rate of 1 ml/min, and detection at 274 nm.
Limitations
- Row count and column-level documentation are absent; field semantics must be inferred after download.
- Last update date is unknown; freshness unverified.
- The dataset's availability, format, and size are unspecified in the input.
Provenance
- Source
- Akhilesh Gupta via paperswithcode
- Collection Method
- Laboratory development and validation of an RP-HPLC and LC-MS/MS method.