Method Development and Validation for the estimation of Azilsartan in Bulk and Pharmaceutical Dosage Form by using HPLC
2021
A simple, sensitive and rapid stability indicating HPLC method was developed and validated for the determination of Azilsartan in bulk and pharmaceutical dosage form. The method was developed by HPLC using a Inertsil C18 (250x4.5mm ID) 5µm column in a isocratic mode with mobile phase constituted by buffer: Methanol and water, pH 3.5 flow rate was 1.0ml/min, column temperature at 20-25°C, UV detection wavelength 240nm and 20µL of injection volume. The retention time of Azilsartan was 3.084min. The validation parameters were in accordance with ICH specifications, assay exhibited a linear range of 50-250µg/ml with regression coefficient 0.998. The limit of detection and quantification were 0.46 µg/ml and 1.42 µg/ml. Accuracy was between 98-102%. The drug was subjected to various stress conditions like peroxide, photolytic, acidic, alkaline, thermal degradations. Stress study of Azilsartan was found susceptible to degrade under hydrolytic (acid and base) conditions. The proposed method has stability indicating the resolution of the main peak from their degradation peak
Keywords:
- Correction
- Source
- Cite
- Save
- Machine Reading By IdeaReader
0
References
0
Citations
NaN
KQI