DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY METHOD AND STRESS DEGRADATION STUDY OF ADAPALENE BY HPTLC METHOD
*Dr. P. N. Sable and P. A. Newale
To develop a new, sensitive, and precise stability indicating high performance thin layer chromatographic method was developed and validated for quantitative determination of Adapalene. The current study deals with development of validated and stability indicating HPTLC method for estimation of Adapalene.Stability study on Adapalene was carried out on hydrolytic conditions such as Acidic, alkaline, oxidative, thermal, photolytic conditions in accordance with International Conference on Harmonization (ICH) guidelines Q1 (R2). The chromatographic separation was performed on aluminium plate pre-coated with silica Gel 60F254 by the use of Tetrahydrofuran: Ethyl acetate: Methanol (7:2:1 v/v/v) as a mobile phase. The wavelength selected for densitometric scanning was 267 nm. Linearity range for Adapalene was revealed that 100-600 ng spot-1. The Rf value of Adapalene was found to be 0.51 (+0.02). The LOD & LOQ were found to be 14.05 and 42.59 ng spot-1 respectively. The developed method was precise and robust, % RSD was found less than 2%. The proposed method can be used for routine quality control analysis of pharmaceutical formulation containing Adapalene.
Keywords: Development, Validation, Degradation, Characterization, HPTLC, Adapalene.
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