A novel UPLC – PDA method for simultaneous determination of hydroquinone, oxybenzone and octinoxate: An in-vitro study

Abstract

Melasma, a type of hyperpigmentation, is a difficult condition to treat. Several topical therapies have been proposed to meet the therapeutic goals of this condition, one of which is the combination of hydroquinone, oxybenzone, and octinoxate. The current study aims to develop a robust and reliable analytical method for determining hydroquinone, oxybenzone, and octinoxate in fixed dosage forms simultaneously. In pharmacopoeias, the scope for simultaneous drug determinations is always limited, so the current work is an attempt to develop a method for routine analysis of this combination in quality control. On Water's Acquity system with an X-Bridge C8 column (100 ​mm 3.0 ​mm, 3.5 ​μm), an isocratic mobile phase of 30:70 v/v acetonitrile and buffer were used to achieve chromatographic separation. The flow rate is 0.5 ​ml per minute, and the detection wavelength is 230 ​nm. By subjecting the APIs to various stressors, the method's ability to indicate stability was demonstrated. The method validation followed ICH guidelines. The results of the research for system acceptability, reproducibility, detection limits, quantitation limits, linearity, accuracy, precision, and specificity are all within acceptable bounds. The reliability and analytical performance of the proposed method for its linearity ranges, system suitability, accuracy, precision, robustness detection, and quantification limits were statistically validated and found to be in consistent with ICH Q2 (R1) recommendations.