Thu, 14 Dec 2017

Development and Validation of A Stability Indicating HPTLC Method For Determination of Adapalene In Bulk Drug

Tanvi Londhe1, Deepali Bansode1*

1.Department of Pharmaceutical Chemistry & Dept. of Quality Assurance Techniques, Bharati Vidyapeeth University, Poona College of Pharmacy, Pune, Maharashtra, India


ABSTRACT

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.

Keywords: Validation, Adapalene, HPTLC, Stability indicating method.


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