COMPARATIVE REVIEW OF RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ADAPALENE, BENZOYL PEROXIDE AND RELATED FORMULATIONS

Moein S. Attar*, Akash C. Kasbe, Sana K. Mulla, Ram S. Sakhare, Vivek B. Panchbhai

Analytical determination of adapalene, benzoyl peroxide, and related compounds has gained significant importance due to their widespread use in dermatological formulations and regulatory monitoring in food and pharmaceutical matrices. The reviewed literature demonstrates that reverse-phase high-performance liquid chromatography (RP-HPLC) remains the most widely applied technique for their simultaneous estimation in gels, bulk drug substances, and flour samples. Most reported methods employ C8 or C18 stationary phases with UV or PDA detection and show satisfactory validation characteristics, including good linearity, precision, accuracy, robustness, and specificity in accordance with ICH guidelines. Stability-indicating approaches have also been developed to separate active components from excipients, preservatives, and stress-induced degradation products, particularly in combination therapies containing adapalene, clindamycin, and benzoyl peroxide. Despite these advances, existing methods predominantly rely on conventional solvent-intensive chromatographic systems and lack comprehensive impurity profiling or bio-analytical applications. Future research should therefore focus on the integration of hyphenated detection techniques, chemometric optimization strategies, and green analytical approaches to enhance sensitivity, sustainability, and regulatory applicability. Collectively, the reviewed studies confirm the reliability of RP-HPLC for routine analysis while highlighting the need for more advanced, stability-focused, and formulation-oriented analytical methodologies.