Stability Indicating UV and RP-HPLC (QBD Optimization), Statistical Correlation for The Determination of Ibuprofen Lysine and Its Related Substance in Tablet Dosage Form

Design of Experiments was used here to produce and verify two effective methods for
measuring Ibuprofen Lysine and related substances using UV-Spectroscopy and RP-HPLC. The
best result for estimating Ibuprofen Lysine was obtained using methanol and wavelength 261nm.
In RP-HPLC, the choice of experimental design was the central composite design, working to tune
acetonitrile, vary buffer pH, alter flow rate and maximize chromatographic results. The highest success
was reached for chloroacetic acid at pH 3.0, using 40:60 acetonitrile (v/v), a flow rate of 2.0 mL/min
and an elution time of only 10 minutes. All methods were fully confirmed by ICH standards, resulting
in high linearity (r = 0.9991) from 0.0086 to 0.0688 mg/mL, good %RSD and study methods. The
methods were proven suitable for daily use because all system suitability parameters passed the
required criteria. High accuracy, precision, specificity and robustness were found in both methods,
so they can be reliably used in quality control for pharmaceuticals.