World Journal of
Pharmaceutical and Life Sciences

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY METHOD OF EVEROLIMUS AND ITS MARKETED FORMULATION

Bandana Kumari* and Pallavi M. Patil

ABSTRACT

The High Performance Thin Layer Chromatography (HPTLC) method developed and validated according to ICH guidelines for the determination of Everolimus (Evr) in the presence of excipient and when subjected to different stress condition. Identification and determination was performed on Pre-coated silica gel G60–F254aluminium sheet (10 cm ×10 cm; thickness: 200 ?m) using Toluene: Ethyl acetate: Methanol in the ration of (6:1:3) as Mobile phase at 283 nm. The linear response for Evr was observed over 50-250 ng/band (r2= 0.999) with the observed value of Rf = 0.63. Limit of Detection (LOD) = 1.707971 ng/band and Limit of Quantification (LOQ) = 5.17567 ng/band were observed. Stress degradation studies were performed to evaluate the stability indicating properties and specificity of the method. Mass spectrometry (MS), Nuclear Magnetic Resonance (NMR) and Infrared spectroscopy (IR) were studied to understand the fragmentation pattern, environment of a hydrogen atom and the functional group present in the drug. This method was used for the quantitative analysis of commercially available dosage form.

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