Methods The determination of febuxostat and the separation of its related substances was performed on a C18 column( 200 mm ×4.6 mm, 5 μm ) . The mobile phase was methanol-acetonitrile-0.05%(w)phosphoric acid (V:V:V=24:46:30) . The flow rate was 1.0 mL·min-1. Ultraviolet absorption detector was set at 315 nm and column temperature at 35 ℃. Results The linear range of febuxostat was between15.7 and 94.3 mg·L-1 ( r = 0. 999 8) . The average recovery was 100.5% with RSD of 1.0%.The related substances of febuxostat could be completely separated from febuxostat. The limit of detection (LOD) was 0.5 ng.
Chiral HPLC methods are often non-aqueous because many chiral stationary phases are not compatible with high levels of water due to stability and performance issues. Using non-aqueous solvents can also improve the resolution and selectivity of chiral separations in HPLC.
To estimate Serratiopeptidase in pharmaceutical products, HPLC (High-Performance Liquid Chromatography) is a commonly used method. A validated HPLC method can separate and quantify Serratiopeptidase in a sample, providing accurate results for quality control purposes in pharmaceutical analysis. It is essential to use appropriate standards and optimize chromatographic conditions for this analysis.
Propylparaben is used as a preservative in solutions for High Performance Liquid Chromatography (HPLC) calibration to prevent microbial growth and maintain stability of the calibration standards over time. Its use helps ensure the accuracy and reliability of the HPLC analysis results by preventing degradation of the calibration standards.
Specificity refers to the ability of an analytical method to accurately measure the analyte of interest in the presence of potential interfering substances. Selectivity, on the other hand, refers to the ability of the method to only detect the analyte of interest while ignoring any other components present in the sample. Both are important parameters in HPLC method validation to ensure accurate and reliable results.
Anthracene is used as a calibration standard in High Performance Liquid Chromatography (HPLC) because it has a well-defined retention time and peaks in the UV-visible spectrum, making it easy to detect and quantify. Its consistent behavior helps in determining retention times, resolving power, and column efficiency during method development and troubleshooting in HPLC.
"RS-HPLC method" means "Related Substance HPLC Method".
the same guidelines for method validation
Method development is a process amenable to continuous improvement
Chiral HPLC methods are often non-aqueous because many chiral stationary phases are not compatible with high levels of water due to stability and performance issues. Using non-aqueous solvents can also improve the resolution and selectivity of chiral separations in HPLC.
Caffeine is commonly used as a standard in the stability study testing (SST) of high-performance liquid chromatography (HPLC) due to its well-defined chemical properties and behavior. It serves as a reliable reference compound because it is readily available, easy to detect, and exhibits consistent retention times under various chromatographic conditions. Additionally, its relatively simple structure allows for straightforward analysis and quantification, making it an ideal choice for method validation and calibration in HPLC applications.
Reproducibility in HPLC ensures that results can be consistently obtained when the experiment is repeated, leading to reliable data. It allows for verification of results by other researchers and ensures the accuracy and reliability of the method. Reproducibility is crucial for validating the robustness of the HPLC method and for ensuring that results are accurate and can be trusted.
it must change by (+- 0.3) to have control in pH meter error
If you can't find it in the literature it can be determined experimentally by titration.
To estimate Serratiopeptidase in pharmaceutical products, HPLC (High-Performance Liquid Chromatography) is a commonly used method. A validated HPLC method can separate and quantify Serratiopeptidase in a sample, providing accurate results for quality control purposes in pharmaceutical analysis. It is essential to use appropriate standards and optimize chromatographic conditions for this analysis.
Propylparaben is used as a preservative in solutions for High Performance Liquid Chromatography (HPLC) calibration to prevent microbial growth and maintain stability of the calibration standards over time. Its use helps ensure the accuracy and reliability of the HPLC analysis results by preventing degradation of the calibration standards.
Assay by HPLC refers to using high-performance liquid chromatography (HPLC) as a technique to quantify the presence and concentration of a specific compound or analyte in a sample. HPLC separates and analyzes components within a mixture based on their interactions with the mobile and stationary phases, allowing for accurate measurement of analyte concentrations. It is commonly used in pharmaceutical, environmental, and food industries for quality control purposes.
Specificity refers to the ability of an analytical method to accurately measure the analyte of interest in the presence of potential interfering substances. Selectivity, on the other hand, refers to the ability of the method to only detect the analyte of interest while ignoring any other components present in the sample. Both are important parameters in HPLC method validation to ensure accurate and reliable results.