A recent study published in Current Pharmaceutical Analysis introduces a robust and validated reverse-phase high-performance liquid chromatography (RP-HPLC) method for the analysis of orlistat, a widely used anti-obesity drug. The method, developed by researchers from KIET School of Pharmacy in India, ensures accurate quantification and is fully compliant with International Council for Harmonisation (ICH) guidelines.
The research team, led by Kandasamy Nagarajan, optimized the chromatographic conditions to achieve high sensitivity and precision. "Our method uses an XBridge C8 column and acetonitrile as the mobile phase, providing sharp peaks and minimal retention times," said Nagarajan. The method was validated for linearity, accuracy, precision, and robustness, with results showing excellent correlation and minimal variability.
The study also evaluated the method's robustness by introducing small variations in detection wavelength and flow rate, confirming its reliability for routine analysis. "This method is not only precise but also cost-effective, reducing solvent use and analysis time," said co-author Snigdha Bhardwaj. The validated method is suitable for quality control labs, ensuring accurate quantification of orlistat in formulations.
The research highlights the method's potential for broader applications in pharmaceutical analysis, emphasizing its alignment with sustainability goals by minimizing solvent use and reducing analysis time. Future work may focus on further validation for stability-indicating methods.
