Novel RP-HPLC Method Development and Validation of Budesonide Suppository

In the current study, a simple and cost-effective stability-indicating RP-HPLC method was developed and validated to estimate Budesonide from bulk and pharmaceutical dosage forms.0.1% formic acid and methanol (15:85 v/v) were employed as the mobile phase with an injection volume of 20μl, and detection was carried out at 244 nm. The developed method was validated as per ICH Q2 guidelines. The RT of Budesonide was determined to be 4.3 ± 0.328 minutes, providing a reliable marker for its identification. The method was found to be linear between 2-12 μg/ml concentration with (R²) of 0.997. This demonstrates the method's ability to measure varying concentrations of Budesonide accurately. Additionally, the percentage recovery of Budesonide was approximately 100%, confirming the accuracy of the developed method. The parameters for the system's suitability have also been found to be within acceptable limits. Force degradation studies reinforced the method's selectivity and sensitivity in detecting Budesonide under various degradation scenarios. In conclusion, our proposed RP-HPLC method provides a sensitive, accurate, and precise way to analyze Budesonide in bulk and pharmaceutical dosage forms.