Quality by Design (QbD) Assisted HPLC Method for Concurrent Estimation of Aloe-Emodin and Adapalene
摘要
Aloe-emodin is an anthraquinone, which is one of the natural products with antioxidant, anti-inflammatory, and antimicrobial properties. On the other hand, Adapalene is a third-generation retinoid that is used in the treatment of acne. Both of these compounds have a lot of therapeutic potential but are poorly soluble in water. In this present study, a straightforward, precise, and robust reverse-phase high-performance liquid chromatography method was developed and validated for the simultaneous determination of these two drugs. Quality by design was used to locate and regulate the key elements of the chromatographic process that affect the performance of the method. Optimization was performed using a Central Composite Design; thus, the method was not only scientifically but also statistically optimized. The separation was achieved using a phenyl silyl column (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of 0.1% v/v glacial acetic acid in water and a mixture of tetrahydrofuran and acetonitrile (30:70 v/v). Both analytes showed peaks with the retention times of 4.66 min for Aloe-emodin and 14.17 min for Adapalene. Linearity was confirmed in the concentration range of 50–150 µg/mL, with the correlation coefficients (R²) equal to 0.999 for both compounds. The recovery experiments (98–102%) and %RSD values (< 2%) were the factors that confirmed the accuracy and precision of the method, while the limit of detection and limit of quantification values showed its sensitivity.