Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF CLASCOTERONE IN TOPICAL CREAM FORMULATION

Yagni Patel* and Priyanka Yadav

ABSTRACT

This study focuses on the development and validation of a Reverse Phase High- Performance Liquid Chromatography (RP-HPLC) method for the simultaneous estimation of Clascoterone in a topical cream formulation. The chromatographic separation was carried out on an Inertsil ODS 3V column (100 × 4.6 mm, 5 μm particle size), utilizing a mobile phase composed of water (pH adjusted to 4.0) and methanol in a 40:60 volume ratio. The flow rate was maintained at 1.4 mL/min, and detection was conducted at 254 nm. Clascoterone exhibited a retention time of around 4.32 minutes. The method was validated in accordance with the International Conference on Harmonisation (ICH) guidelines by assessing critical parameters such as accuracy, precision, linearity, limits of detection and quantification (LOD and LOQ), robustness, and forced degradation studies. The validation results confirm that themethod is reliable and suitable for the routine quantification of Clascoterone in topical cream formulations.

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