Adapalene

To develop a new, economical, precise and accurate stability indicating HPTLC method was developed and validated for the determination of Adapalene in bulk drug. The present study deals with development and validation of stability indicating HPTLC method for estimation of Adapalene. Chromatographic separation was performed on aluminium plate pre-coated with Silica Gel 60 F254 using Tetrahydrofuran: 2-Propanol: Water (3:3:3 v/v/v) as a mobile phase. The wavelength selected for densitometric scanning was 230 nm. Regression plots revealed linear relationship in the concentration range of 20-120 ng spot-1. The Rf value of Adapalene was found to be 0.76 (±0.02).The LOD and LOQ were found to be 3.15 and 9.57 ng spot-1respectively. The method was validated as per International Conference on Harmonization (ICH) guidelines, demonstrating to be accurate and precise within the corresponding linearity range of titled analytes. Inherent stability of the drug was studied by exposing drug to acid, alkali, oxidative, photolytic and thermal conditions. Relevant degradation was found to take place under these conditions. The proposed method has been validated as per ICH Q2 (R1) guidelines. This method can be used for routine quality control analysis of Adapalene in bulk drug.

Topical drug delivery systems have been utilized for centuries for the treatment of local skin disorders. One side the topical applications of the drug provides the potential advantages of delivering drug straightly to the site of action and delivering drug for extended period of time at the effected site that mainly acts at the related regions. On the other hand, topical delivery system elevates the contact time and mean resident time of drug. The aim of the work is to develop & characterize adapalene emulgel formulation. Adapalene emulgel formulations were prepared by dispersing Carbopol 934 in distilled water with constant stirring at a moderate speed, then the pH was adjusted to 6 - 6.5 using Triethanolamine. Evaluation of the adapalene emulgel was carried out for Physical appearance, Rheological study, pH values, Spreadability, Drug content determination, In vitro release study, Accelerated stability studies. It was noticed that all formulations were liquefied and diluted at the end of the experiments, indicating water diffusion through the membrane. The accelerated stability studies were performed according to ICH guidelines for three months & emulgels were found to be stable in differing temperature. The results demonstrate that the release of the drug is dependent on viscosity of the polymer used.