Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Rilpivirine Hydrochloride in Tablet Dosage Form
DOI:
https://doi.org/10.7439/ijapa.v4i2.78Abstract
A simple, sensitive, rapid and reproducible HPLC Method was developed and validated for estimation of Rilpivirine in the presence of degradation products generated from forced decomposition studies. The analysis was carried out on Hypersil BDS C18, 250 X 4.6mm, 5? column using a mixture of ammonium acetate Buffer (pH to 6.0 0.05) and Acetonitrile in the proportion 55:45 respectively as a mobile phase at a flow rate of 1.2 mL/minute. The wavelength selected for the analysis was 300 nm. The peak for Rilpivirine HCl was observed at 10.33 minute. A linear response was observed in the range of 12.5 - 62.5 ?g/mL with a correlation coefficient of 0.999. The method was validated for specificity, linearity, precision, accuracy and robustness. The obtained results were indicating that the method is selective in analysis of Rilpivirine in the presence of degradation products formed under various stress conditions.Downloads
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