Development and Validation of Stability Indicating HPTLC Method for Esomeprazole Magnesium Trihydrate

Abstract

A new, simple, precise, rapid, selective and specific stability indicating HPTLC method has been developed and validated for Esomeprazole Magnesium Trihydrate (ESOM). Stability indicating HPTLC method was developed & validated for estimation of Esomeprazole Magnesium Trihydrate (ESOM). Stability indicating capability is established by forced degradation of ESOM to acid, alkali, oxidation, thermal, neutral and photo degradation as per ICH guidelines Q1A (R2) and Q1B. Separation was achieved on a Precoated Silica Gel 60F254 Plates with 250 μm thickness by using 1,4 - Dioxane : Toluene : Methanol (6:4:1, v/v/v) as mobile phase. Detection was carried out at 304 nm wavelength. The method was validated as per ICH guidelines Q2 (R1). The linearity of the proposed method was found to be in the range of 300-1900 ng/spot concentrations with correlation coefficient R2=0.9989. For ESOM, Specificity of the developed method was established by determining the peak purity of the peaks of the drugs in a stress samples by scanning peak at peak start, peak apex and peak end. Correlation between them showed high level of purity and significant separation from pure ESOM peak and peak of degradation prodcts. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating method.