Development and validation of a method to quantify methylprednisolone aceponate in cream by micellar liquid chromatography.

Adventan cream is a widely prescribed topical medication used to treat various skin disorders. We have developed a method based on micellar liquid chromatography to quantify its active component, methylprednisolone aceponate, which is an essential step for effective quality control. Samples were mixed with methanol and mobile phase to achieve a drug concentration of approximately 1 mg/L, filtered, and directly injected. Chromatographic analysis was performed in under 10 min with adequate resolution, using a mobile phase composed of 0.10 M sodium dodecyl sulfate-4.0%, v/v, 1-butanol, buffered at pH 3 with a phosphate salt, running at 1 mL/min under isocratic mode through a C18 column. Absorbance wavelength detection was set to 245 nm. The method was validated according to International Council for Harmonisation guidelines to assess its analytical performance in terms of specificity, instrumental linearity (r2 > 0.9996), calibration range (0.25 to 2.5 mg/L), limit of detection (0.09 mg/L), limit of quantification (0.26 mg/L), and robustness, as well as method precision (RSD < 2.8%) and trueness (relative recovery, 98-102.5%). It was also successfully applied to commercial samples. Additionally, the retention mechanism was investigated by determining the constants of the partition equilibria occurring in the column and demonstrating that both surfactant and organic solvent contribute similarly to elution strength. The method was safe and ecofriendly, due to the low volume of toxic and volatile organic solvents employed, easy to handle, cost-effective, semi-automated, and with a high sample throughput, making it well suited for routine pharmaceutical quality control.